- [Home](/) › - [FdaApprovalPulse](/v/fdaapprovalpulse) › - [Hubs](/hub/fdaapprovalpulse) › - All record reports # FdaApprovalPulse: all 386 record reports, page 1 of 2 Every FdaApprovalPulse record report, 200 per page, grouped by state. Records 1 to 200: Advanced Medical Solutions Limited: PMA supplement approved for LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hern to Abiomed, Inc.: PMA supplement approved for Impella CP with SmartAssist. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). 1 [2](/hub/fdaapprovalpulse/records/2) - [Advanced Medical Solutions Limited: PMA supplement approved for LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hern](/report/fdaapprovalpulse/advanced-medical-solutions-limited-plymouth--pma-p220024-s007) - [Croma-Pharma GmbH: PMA supplement approved for saypha® ChiQ™](/report/fdaapprovalpulse/croma-pharma-gmbh-leobendorf--pma-p250021-s002) - [Croma-Pharma GmbH: PMA supplement approved for saypha® ChiQ™](/report/fdaapprovalpulse/croma-pharma-gmbh-leobendorf--pma-p250021-s001) - [Ferrosan Meidcal Devices A/S: PMA supplement approved for SURGIFOAM® Absorbable Gelatin Sponge](/report/fdaapprovalpulse/ferrosan-meidcal-devices-a-s-soeborg--pma-p990004-s080) - [Insightec: PMA supplement approved for Exablate Model 4000 System](/report/fdaapprovalpulse/insightec-tirat-carmel--pma-p150038-s044) - [Kardium, Inc.: PMA supplement approved for Globe® Catheter and Globe® Pulsed Field System](/report/fdaapprovalpulse/kardium-inc-burnaby--pma-p240044-s001) - [Keri Medical SA: PMA supplement approved for TOUCH® CMC 1 Prosthesis](/report/fdaapprovalpulse/keri-medical-sa-1228-plan-les-ouates--pma-p240020-s004) - [Mainstay Medical Limited: PMA supplement approved for ReActiv8 Implantable Neurostimulation System](/report/fdaapprovalpulse/mainstay-medical-limited-swords-co-dublin--pma-p190021-s012) - [Med-El Corp.: PMA supplement approved for MED-EL Cochlear Implant System](/report/fdaapprovalpulse/med-el-corp-innsbruck--pma-p000025-s136) - [Novocure, GmbH: PMA supplement approved for Novocure GmbH’s Optune Gio](/report/fdaapprovalpulse/novocure-gmbh-baar--pma-p100034-s045) - [Novocure, GmbH: PMA supplement approved for Optune Gio](/report/fdaapprovalpulse/novocure-gmbh-baar--pma-p100034-s042) - [Novocure, GmbH: PMA supplement approved for Optune Lua®](/report/fdaapprovalpulse/novocure-gmbh-baar--pma-p230042-s008) - [Novocure, GmbH: PMA supplement approved for Optune Pax®](/report/fdaapprovalpulse/novocure-gmbh-baar--pma-p250034-s001) - [OrbusNeich Medical (Shenzhen) Co., Ltd.: PMA supplement approved for Scoreflex NC Scoring PTCA Catheter](/report/fdaapprovalpulse/orbusneich-medical-shenzhen-co-ltd-shenzhen--pma-p200041-s005) - [Organox Limited: PMA supplement approved for OrganOx metra® System](/report/fdaapprovalpulse/organox-limited-oxford--pma-p200035-s038) - [Organox Limited: PMA supplement approved for OrganOx metra® System](/report/fdaapprovalpulse/organox-limited-oxford--pma-p200035-s037) - [Organox Limited: PMA supplement approved for OrganOx metra® System](/report/fdaapprovalpulse/organox-limited-oxford--pma-p200035-s033) - [Perimeter Medical Imaging Ai, Inc.: PMA supplement approved for Claire™ OCT System](/report/fdaapprovalpulse/perimeter-medical-imaging-ai-inc-toronto--pma-p250008-s001) - [Premia Spine, Ltd.: PMA supplement approved for TOPS™ System](/report/fdaapprovalpulse/premia-spine-ltd-netanya--pma-p220002-s009) - [Proverum, Ltd.: PMA supplement approved for ProVee System for BPH](/report/fdaapprovalpulse/proverum-ltd-dublin--pma-p250011-s006) - [Q-Med AB: PMA supplement approved for Restylane® Contour](/report/fdaapprovalpulse/q-med-ab-uppsala--pma-p140029-s058) - [Q-Med AB: PMA supplement approved for Restylane® Contour](/report/fdaapprovalpulse/q-med-ab-uppsala--pma-p140029-s057) - [QIAGEN GmbH: PMA supplement approved for QIAGEN therascreen® FGFR RGQ RT-PCR Kit](/report/fdaapprovalpulse/qiagen-gmbh-hilden--pma-p180043-s010) - [Rayner Intraocular Lenses , Ltd.: PMA supplement approved for RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X](/report/fdaapprovalpulse/rayner-intraocular-lenses-ltd-hove-e-sussex--pma-p060011-s045) - [Saluda Medical Pty, Ltd.: PMA supplement approved for CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application](/report/fdaapprovalpulse/saluda-medical-pty-ltd-atarmon--pma-p190002-s039) - [Saluda Medical Pty, Ltd.: PMA supplement approved for Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042)](/report/fdaapprovalpulse/saluda-medical-pty-ltd-atarmon--pma-p190002-s038) - [Seikagaku Corp.: PMA supplement approved for Gel-One](/report/fdaapprovalpulse/seikagaku-corp-tokyo--pma-p080020-s056) - [Seikagaku Corp.: PMA supplement approved for SUPARTZ FX](/report/fdaapprovalpulse/seikagaku-corp-tokyo--pma-p980044-s067) - [Stryker Leibinger GmbH & Co KG: PMA supplement approved for Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant](/report/fdaapprovalpulse/stryker-leibinger-gmbh-and-co-kg-freiburg--pma-p130014-s022) - [Terumo Medical Corporation: PMA supplement approved for MISAGO(TM) RX Self-expanding Peripheral Stent](/report/fdaapprovalpulse/terumo-medical-corporation-hatagaya--pma-p140002-s032) - [Vascutek, Ltd.: PMA supplement approved for Thoraflex™ Hybrid](/report/fdaapprovalpulse/vascutek-ltd-inchinnan--pma-p210006-s018) ## Arizona - [Bard Peripheral Vascular, Inc.: PMA approval for Liverty™ TIPS Stent Graft](/report/fdaapprovalpulse/bard-peripheral-vascular-inc-tempe-az--pma-p250050-orig) - [Bard Peripheral Vascular, Inc.: PMA supplement approved for LifeStent 5F Vascular Stent System](/report/fdaapprovalpulse/bard-peripheral-vascular-inc-tempe-az--pma-p070014-s068) - [Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA approval for VENTANA PTEN (SP218) RxDx Assay](/report/fdaapprovalpulse/ventana-medical-systems-inc-roche-tissue-diagnostics-tucson-az--pma-p250031-orig) - [Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA supplement approved for VENTANA MET (SP44) RxDx Assay](/report/fdaapprovalpulse/ventana-medical-systems-inc-roche-tissue-diagnostics-tucson-az--pma-p240037-s003) - [Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA supplement approved for VENTANA MMR RxDx Panel](/report/fdaapprovalpulse/ventana-medical-systems-inc-roche-tissue-diagnostics-tucson-az--pma-p210001-s016) - [Ventana Medical Systems, Inc.: PMA supplement approved for HER2 Dual ISH DNA Probe Cocktail](/report/fdaapprovalpulse/ventana-medical-systems-inc-tucson-az--pma-p190031-s015) - [Ventana Medical Systems, Inc.: PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody](/report/fdaapprovalpulse/ventana-medical-systems-inc-tucson-az--pma-p990081-s060) - [Ventana Medical Systems, Inc.: PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody](/report/fdaapprovalpulse/ventana-medical-systems-inc-tucson-az--pma-p990081-s058) - [Ventana Medical Systems, Inc.: PMA supplement approved for VENTANA HER2 Dual ISH DNA Probe Cocktail](/report/fdaapprovalpulse/ventana-medical-systems-inc-tucson-az--pma-p190031-s016) - [Ventana Medical Systems: PMA supplement approved for VENTANA MMR RxDx Panel](/report/fdaapprovalpulse/ventana-medical-systems-tucson-az--pma-p200019-s014) - [W. L. Gore & Associates, Inc.: PMA supplement approved for GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-flagstaff-az--pma-p230023-s012) - [W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-phonix-az--pma-p050006-s119) - [W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® AAA Endoprosthesis](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-phonix-az--pma-p020004-s205) - [W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-phonix-az--pma-p020004-s207) - [W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-flagstaff-az--pma-p210032-s026) - [W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-flagstaff-az--pma-p160021-s051) - [W. L. Gore and Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® Conformable AAA Endoprosthesis](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-phonix-az--pma-p200030-s025) - [W. L. Gore and Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® Conformable AAA Endoprosthesis](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-phonix-az--pma-p200030-s024) ## California - [ABBOTT MEDICAL: PMA supplement approved for Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p030035-s211) - [ABBOTT MEDICAL: PMA supplement approved for Assurity MRI / Endurity MRI Pacemakers](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p140033-s101) - [ABBOTT MEDICAL: PMA supplement approved for Assurity, Assurity+, Endurity, Accent family of Pacemakers](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p880086-s345) - [ABBOTT MEDICAL: PMA supplement approved for Aveir™ Leadless System](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p150035-s035) - [ABBOTT MEDICAL: PMA supplement approved for Aveir VR (LSCD111); DR Delivery Catheter (LSCD201)](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p150035-s038) - [ABBOTT MEDICAL: PMA supplement approved for Aveir VR Leadless System](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p150035-s041) - [ABBOTT MEDICAL: PMA supplement approved for AVEIR VR Real-World Evidence Study](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p150035-s042) - [ABBOTT MEDICAL: PMA supplement approved for Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p910023-s482) - [ABBOTT MEDICAL: PMA supplement approved for Esprit™ BTK Everolimus Eluting Resorbable Scaffold System](/report/fdaapprovalpulse/abbott-medical-santa-clara-ca--pma-p230036-s020) - [ABBOTT MEDICAL: PMA supplement approved for Esprit™ BTK Everolimus Eluting Resorbable Scaffold System](/report/fdaapprovalpulse/abbott-medical-santa-clara-ca--pma-p230036-s017) - [ABBOTT MEDICAL: PMA supplement approved for HeartMate 3™ Left Ventricular Assist System](/report/fdaapprovalpulse/abbott-medical-pleasanton-ca--pma-p160054-s121) - [ABBOTT MEDICAL: PMA supplement approved for HeartMate 3™ Left Ventricular Assist System](/report/fdaapprovalpulse/abbott-medical-pleasanton-ca--pma-p160054-s122) - [ABBOTT MEDICAL: PMA supplement approved for HeartMate 3™ Left Ventricular Assist System (LVAS)](/report/fdaapprovalpulse/abbott-medical-pleasanton-ca--pma-p160054-s125) - [ABBOTT MEDICAL: PMA supplement approved for HeartMate II Left Ventricular Assist System](/report/fdaapprovalpulse/abbott-medical-pleasanton-ca--pma-p060040-s123) - [ABBOTT MEDICAL: PMA supplement approved for HeartMate II Left Ventricular Assist System (LVAS)](/report/fdaapprovalpulse/abbott-medical-pleasanton-ca--pma-p060040-s124) - [ABBOTT MEDICAL: PMA supplement approved for Microny family of Pacemakers](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p970013-s099) - [ABBOTT MEDICAL: PMA supplement approved for Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra A](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p030054-s440) - [ABBOTT MEDICAL: PMA supplement approved for The AVEIR Leadless Pacemaker (LP)](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p150035-s039) - [ABBOTT MEDICAL: PMA supplement approved for UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isof](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p960013-s133) - [ABBOTT MEDICAL: PMA supplement approved for UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isof](/report/fdaapprovalpulse/abbott-medical-sylmar-ca--pma-p960030-s084) - [Abbott Vascular, Inc.: PMA supplement approved for Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Clo](/report/fdaapprovalpulse/abbott-vascular-inc-redwood-ca--pma-p960043-s128) - [Abbott: PMA supplement approved for CentriMag™ Circulatory Support System](/report/fdaapprovalpulse/abbott-pleasanton-ca--pma-p170038-s030) - [Acu Focus, Inc.: PMA supplement approved for IC-8 Apthera Intraocular Lens (IOL)](/report/fdaapprovalpulse/acu-focus-inc-irvine-ca--pma-p210005-s010) - [Agilent Technologies, Inc.: PMA supplement approved for MAGE-A4 IHC 1F9 pharmDx](/report/fdaapprovalpulse/agilent-technologies-inc-carpinteria-ca--pma-p230016-s003) - [Agilent Technologies, Inc.: PMA supplement approved for PD-L1 IHC 28-8 pharmDx](/report/fdaapprovalpulse/agilent-technologies-inc-santa-clara-ca--pma-p150025-s018) - [Allergan: PMA supplement approved for Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive](/report/fdaapprovalpulse/allergan-irvine-ca--pma-p110033-s091) - [Allergan: PMA supplement approved for Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Impla](/report/fdaapprovalpulse/allergan-irvine-ca--pma-p020056-s064) - [Allergan: PMA supplement approved for SKINVIVE by JUVEDERM®](/report/fdaapprovalpulse/allergan-irvine-ca--pma-p110033-s099) - [Allergan: PMA supplement approved for Ultra, Ultra XC, Ultra Plus XC](/report/fdaapprovalpulse/allergan-irvine-ca--pma-p050047-s098) - [AutoGenomics, Inc.: PMA supplement approved for AvertD and AvertD Buccal Sample Collection Kit](/report/fdaapprovalpulse/autogenomics-inc-carlsbad-ca--pma-p230032-s005) - [Balt USA, LLC: PMA supplement approved for SQUID Liquid Embolic Agent (LEA)](/report/fdaapprovalpulse/balt-usa-llc-irvine-ca--pma-p250009-s001) - [Balt USA, LLC: PMA supplement approved for SQUID Liquid Embolic Agent (LEA)](/report/fdaapprovalpulse/balt-usa-llc-irvine-ca--pma-p250009-s002) - [Biosense Webster, Inc.: PMA supplement approved for Dual Energy THERMOCOOL SMARTTOUCH SF™ System](/report/fdaapprovalpulse/biosense-webster-inc-irvine-ca--pma-p030031-s141) - [Biosense Webster, Inc.: PMA supplement approved for THERMOCOOL SMARTTOUCH® SF Catheter](/report/fdaapprovalpulse/biosense-webster-inc-irvine-ca--pma-p030031-s142) - [Biosense Webster, Inc.: PMA supplement approved for VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)](/report/fdaapprovalpulse/biosense-webster-inc-irvine-ca--pma-p240006-s016) - [Biosense Webster, Inc.: PMA supplement approved for VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System](/report/fdaapprovalpulse/biosense-webster-inc-irvine-ca--pma-p030031-s143) - [Boston Scientific Corp: PMA supplement approved for Celestia Implantable Pulse Generator, Celestia External Trial Stimulator](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p030017-s392) - [Boston Scientific Corp: PMA supplement approved for Deep Brain Stimulation (DBS) Systems](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p150031-s092) - [Boston Scientific Corp: PMA supplement approved for Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Syste](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p030017-s399) - [Boston Scientific Corp: PMA supplement approved for Spinal Cord Stimulation (SCS)](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p030017-s393) - [Boston Scientific Corp: PMA supplement approved for Vercise DBS Systems](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p150031-s100) - [Boston Scientific Corp: PMA supplement approved for VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p150031-s084) - [Boston Scientific Corp: PMA supplement approved for Vercise Genus DBS Systems; Vercise Gevia DBS Systems](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p150031-s098) - [Boston Scientific Corp: PMA supplement approved for WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p030017-s396) - [Carl Zeiss Meditec, Inc.: PMA supplement approved for MEL 90 Excimer Laser](/report/fdaapprovalpulse/carl-zeiss-meditec-inc-dublin-ca--pma-p060004-s010) - [Carl Zeiss Meditec, Inc.: PMA supplement approved for VISUMAX 800 Femtosecond Laser](/report/fdaapprovalpulse/carl-zeiss-meditec-inc-dublin-ca--pma-p150040-s024) - [Channel Medsystems, Inc.: PMA supplement approved for Cerene® Cryotherapy Device](/report/fdaapprovalpulse/channel-medsystems-inc-emeryville-ca--pma-p180032-s023) - [Edwards Lifesciences, LLC: PMA approval for Autus Size-Adjustable Valve](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p260007-orig) - [Edwards Lifesciences, LLC: PMA supplement approved for Edwards Crimper: 9600CR](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p140031-s192) - [Edwards Lifesciences, LLC: PMA supplement approved for Edwards EVOQUE Tricuspid Valve Replacement System](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p230013-s029) - [Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p200015-s069) - [Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p200015-s076) - [Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Ultra™ RESILIA Transcatheter Heart Valve](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p140031-s202) - [Edwards Lifesciences, LLC: PMA supplement approved for EVOQUE Tricuspid Valve Replacement System](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p230013-s033) - [Edwards Lifesciences, LLC: PMA supplement approved for EVOQUE Tricuspid Valve Replacement System](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p230013-s027) - [Edwards Lifesciences, LLC: PMA supplement approved for INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p150048-s100) - [Edwards Lifesciences, LLC: PMA supplement approved for PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p220003-s028) - [Edwards Lifesciences, LLC: PMA supplement approved for PASCAL Precision Transcatheter Valve Repair System](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p220003-s032) - [Edwards Lifesciences, LLC: PMA supplement approved for PASCAL Precision Transcatheter Valve Repair System](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p220003-s029) - [Edwards Lifesciences, LLC: PMA supplement approved for TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33](/report/fdaapprovalpulse/edwards-lifesciences-llc-irvine-ca--pma-p150048-s094) - [Endologix, LLC: PMA supplement approved for Alto Abdominal Stent Graft System](/report/fdaapprovalpulse/endologix-llc-santa-rosa-ca--pma-p120006-s045) - [Ev3 Neurovascular: PMA supplement approved for Onyx™ Liquid Embolic System (LES)](/report/fdaapprovalpulse/ev3-neurovascular-irvine-ca--pma-p030004-s042) - [Ev3 Neurovascular: PMA supplement approved for Onyx™ Liquid Embolic System (Onyx™ LES)](/report/fdaapprovalpulse/ev3-neurovascular-irvine-ca--pma-p030004-s039) - [Farapulse, Inc.: PMA supplement approved for FARAPULSE™ Pulsed Field Ablation System](/report/fdaapprovalpulse/farapulse-inc-menlo-park-ca--pma-p230030-s018) - [Farapulse, Inc.: PMA supplement approved for FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTA](/report/fdaapprovalpulse/farapulse-inc-menlo-park-ca--pma-p230030-s016) - [Farapulse, Inc.: PMA supplement approved for FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FA](/report/fdaapprovalpulse/farapulse-inc-menlo-park-ca--pma-p230030-s024) - [Freenome, LLC: PMA approval for SimpleScreen™ CRC](/report/fdaapprovalpulse/freenome-llc-brisbane-ca--pma-p250029-orig) - [Guardant Health, Inc.: PMA approval for Guardant360® Liquid CDx](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p250027-orig) - [Guardant Health, Inc.: PMA supplement approved for Guardant360 CDx](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p200010-s029) - [Guardant Health, Inc.: PMA supplement approved for Guardant360 CDx](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p200010-s027) - [Guardant Health, Inc.: PMA supplement approved for Guardant360® CDx](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p200010-s024) - [Guardant Health, Inc.: PMA supplement approved for Guardant360® CDx](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p200010-s032) - [Guardant Health, Inc.: PMA supplement approved for Guardant360® CDx](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p200010-s025) - [Guardant Health, Inc.: PMA supplement approved for Shield](/report/fdaapprovalpulse/guardant-health-inc-palo-alto-ca--pma-p230009-s010) - [Illumina, Inc.: PMA supplement approved for TruSight Oncology Comprehensive](/report/fdaapprovalpulse/illumina-inc-san-diego-ca--pma-p230011-s006) - [Illumina, Inc.: PMA supplement approved for TruSight Oncology Comprehensive](/report/fdaapprovalpulse/illumina-inc-san-diego-ca--pma-p230011-s002) - [Irvine Biomedical, Inc.: PMA supplement approved for Ampere Generator](/report/fdaapprovalpulse/irvine-biomedical-inc-irvine-ca--pma-p040014-s051) - [Irvine Biomedical, Inc.: PMA supplement approved for Ampere Generator](/report/fdaapprovalpulse/irvine-biomedical-inc-irvine-ca--pma-p060019-s059) - [Irvine Biomedical,Inc.(Ibi): PMA supplement approved for Ampere Generator](/report/fdaapprovalpulse/irvine-biomedical-inc-ibi-irvine-ca--pma-p040042-s059) - [JenaValve Technology, Inc.: PMA supplement approved for Trilogy Transcatheter Heart Valve System](/report/fdaapprovalpulse/jenavalve-technology-inc-irvine-ca--pma-p250024-s002) - [JenaValve Technology, Inc.: PMA supplement approved for Trilogy Transcatheter Heart Valve System](/report/fdaapprovalpulse/jenavalve-technology-inc-irvine-ca--pma-p250024-s001) - [Johnson & Johnson Surgical Vision, Inc.: PMA supplement approved for TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600)](/report/fdaapprovalpulse/johnson-and-johnson-surgical-vision-inc-irvine-ca--pma-p980040-s182) - [MedAlliance, LLC: PMA approval for SELUTION SLR™ 014 PTCA Drug-Eluting Balloon](/report/fdaapprovalpulse/medalliance-llc-irvine-ca--pma-p250041-orig) - [Medtronic Minimed, Inc.: PMA supplement approved for MiniMed 780G System](/report/fdaapprovalpulse/medtronic-minimed-inc-northridge-ca--pma-p160017-s140) - [Medtronic Minimed, Inc.: PMA supplement approved for MiniMed 780G System](/report/fdaapprovalpulse/medtronic-minimed-inc-northridge-ca--pma-p160017-s135) - [Medtronic Minimed, Inc.: PMA supplement approved for Simplera Sync Sensor](/report/fdaapprovalpulse/medtronic-minimed-inc-northridge-ca--pma-p250012-s008) - [Medtronic, Inc.: PMA supplement approved for Symplicity Spyral™ Renal Denervation System](/report/fdaapprovalpulse/medtronic-inc-santa-rosa-ca--pma-p220026-s014) - [Medtronic, Inc.: PMA supplement approved for Symplicity Spyral™ Renal Denervation System](/report/fdaapprovalpulse/medtronic-inc-santa-rosa-ca--pma-p220026-s017) - [Mentor Corp.: PMA supplement approved for MENTOR™ MemoryGel™ Breast Implants](/report/fdaapprovalpulse/mentor-corp-irvin-ca--pma-p030053-s085) - [Mentor Corp.: PMA supplement approved for MENTOR™ MemoryGel™ Enhance Breast Implants](/report/fdaapprovalpulse/mentor-corp-irvin-ca--pma-p030053-s083) - [Mentor Worldwide, LLC: PMA supplement approved for MENTOR™ MemoryShape™ Breast Implants](/report/fdaapprovalpulse/mentor-worldwide-llc-irvin-ca--pma-p060028-s058) - [Microcube, LLC: PMA supplement approved for Minitouch 3.8 Era System (Minitouch System)](/report/fdaapprovalpulse/microcube-llc-fremont-ca--pma-p230002-s002) - [Motiva USA, LLC: PMA supplement approved for Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk R](/report/fdaapprovalpulse/motiva-usa-llc-santa-barbara-ca--pma-p230005-s002) - [Motiva USA, LLC: PMA supplement approved for Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants](/report/fdaapprovalpulse/motiva-usa-llc-santa-barbara-ca--pma-p230005-s005) - [NeuroPace, Inc.: PMA supplement approved for NeuroPace® RNS® System](/report/fdaapprovalpulse/neuropace-inc-mountain-view-ca--pma-p100026-s100) - [NeuroPace, Inc.: PMA supplement approved for NeuroPace® RNS® System](/report/fdaapprovalpulse/neuropace-inc-mountain-view-ca--pma-p100026-s101) - [Neuros Medical, Inc.: PMA supplement approved for Altius® Direct Electrical Nerve Stimulation System](/report/fdaapprovalpulse/neuros-medical-inc-aliso-viejo-ca--pma-p230020-s006) - [Neuspera Medical, Inc.: PMA supplement approved for Neuspera Sacral Neuromodulation (SNM) System](/report/fdaapprovalpulse/neuspera-medical-inc-san-jose-ca--pma-p240031-s005) - [Nevro Corporation: PMA supplement approved for HFX Dynamis System](/report/fdaapprovalpulse/nevro-corporation-redwood-city-ca--pma-p130022-s069) - [Pulmonx Corporation: PMA supplement approved for Zephyr Endobronchial Valve System](/report/fdaapprovalpulse/pulmonx-corporation-redwood-city-ca--pma-p180002-s032) - [Recor Medical, Inc.: PMA supplement approved for Paradise™ Ultrasound Renal Denervation System (Paradise System)](/report/fdaapprovalpulse/recor-medical-inc-palo-alto-ca--pma-p220023-s011) - [Renata Medical, Inc.: PMA supplement approved for Minima Pro Stent System](/report/fdaapprovalpulse/renata-medical-inc-newport-beach-ca--pma-p240003-s006) - [Renata Medical, Inc.: PMA supplement approved for Minima Stent System; Minima Pro Stent System](/report/fdaapprovalpulse/renata-medical-inc-newport-beach-ca--pma-p240003-s008) - [Roche Molecular Systems, Inc.: PMA supplement approved for cobas HPV](/report/fdaapprovalpulse/roche-molecular-systems-inc-pleasanton-ca--pma-p190028-s023) - [Rxsight, Inc.: PMA supplement approved for RxSight Light Adjustable Lens and Light Delivery Device](/report/fdaapprovalpulse/rxsight-inc-aliso-viejo-ca--pma-p160055-s056) - [Rxsight, Inc.: PMA supplement approved for RxSight Light Adjustable Lens; Light Delivery Device](/report/fdaapprovalpulse/rxsight-inc-aliso-viejo-ca--pma-p160055-s054) - [Rxsight, Inc.: PMA supplement approved for RxSight Light Adjustable Lens; Light Delivery Device](/report/fdaapprovalpulse/rxsight-inc-aliso-viejo-ca--pma-p160055-s055) - [Shockwave Medical, Inc.: PMA supplement approved for Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Ae](/report/fdaapprovalpulse/shockwave-medical-inc-santa-clara-ca--pma-p200039-s021) - [Spineart USA, Inc.: PMA approval for BAGUERA®C Cervical Disc Prosthesis](/report/fdaapprovalpulse/spineart-usa-inc-laguna-hills-ca--pma-p250042-orig) - [Spineart USA, Inc.: PMA supplement approved for BAGUERA®C Cervical Disc Prosthesis](/report/fdaapprovalpulse/spineart-usa-inc-laguna-hills-ca--pma-p250042-s002) ## Colorado - [Hepquant, LLC: PMA approval for HepQuant SHUNT® Liver Diagnostic Test](/report/fdaapprovalpulse/hepquant-llc-aurora-co--pma-p220016-orig) - [Spectranetics Corp.: PMA supplement approved for ELCA Coronary Laser Atherectomy Catheters](/report/fdaapprovalpulse/spectranetics-corp-colorado-springs-co--pma-p910001-s126) - [Synergy Spine Solutions, Inc.: PMA supplement approved for Synergy Disc](/report/fdaapprovalpulse/synergy-spine-solutions-inc-louisville-co--pma-p250028-s003) - [Xvivo Perfusion, Inc.: PMA supplement approved for XPS™ with Steen Solution™ Perfusate](/report/fdaapprovalpulse/xvivo-perfusion-inc-englewood-co--pma-p180014-s014) ## Connecticut - [Defibtech, LLC: PMA supplement approved for Defibtech Automated External Defibrillator (AED) Systems](/report/fdaapprovalpulse/defibtech-llc-guilford-ct--pma-p160032-s016) - [Defibtech, LLC: PMA supplement approved for Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline V](/report/fdaapprovalpulse/defibtech-llc-guilford-ct--pma-p160032-s015) - [Defibtech, LLC: PMA supplement approved for Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AED](/report/fdaapprovalpulse/defibtech-llc-guilford-ct--pma-p160032-s017) - [Defibtech, LLC: PMA supplement approved for Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, L](/report/fdaapprovalpulse/defibtech-llc-guilford-ct--pma-p160032-s014) ## Florida - [Biomet Microfixation, Inc.: PMA supplement approved for Total Temporomandibular Joint Replacement System](/report/fdaapprovalpulse/biomet-microfixation-inc-jacksonville-fl--pma-p020016-s010) - [Cerenovus, Inc.: PMA supplement approved for TRUFILL n-BCA Liquid Embolic System](/report/fdaapprovalpulse/cerenovus-inc-miami-fl--pma-p990040-s037) - [Cordis US Corporation: PMA supplement approved for Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Ven](/report/fdaapprovalpulse/cordis-us-corporation-miami-lakes-fl--pma-p040044-s113) - [Cordis US Corporation: PMA supplement approved for Exoseal Vascular Closure Device](/report/fdaapprovalpulse/cordis-us-corporation-miami-lakes-fl--pma-p100013-s034) - [Cordis US Corporation: PMA supplement approved for PRECISE PRO RX Nitinol Stent System](/report/fdaapprovalpulse/cordis-us-corporation-miami-lakes-fl--pma-p030047-s055) - [Lenstec, Inc.: PMA supplement approved for ClearView™ HD intraocular lens (IOL)](/report/fdaapprovalpulse/lenstec-inc-st-petersburg-fl--pma-p200020-s013) ## Georgia - [ABBOTT MEDICAL: PMA supplement approved for CardioMEMS HF System](/report/fdaapprovalpulse/abbott-medical-atlanta-ga--pma-p100045-s090) - [ABBOTT MEDICAL: PMA supplement approved for CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Appl](/report/fdaapprovalpulse/abbott-medical-atlanta-ga--pma-p100045-s091) - [Artivion, Inc.: PMA approval for AMDS Hybrid Prosthesis](/report/fdaapprovalpulse/artivion-inc-kennesaw-ga--pma-p250055-orig) - [Cryolife, Inc.: PMA supplement approved for BioGlue® Surgical Adhesive](/report/fdaapprovalpulse/cryolife-inc-kennesaw-ga--pma-p010003-s043) ## Illinois - [Abbott Molecular, Inc.: PMA supplement approved for Alinity m HR HPV](/report/fdaapprovalpulse/abbott-molecular-inc-des-plaines-il--pma-p230003-s015) - [Abbott Molecular, Inc.: PMA supplement approved for Alinity m HR HPV](/report/fdaapprovalpulse/abbott-molecular-inc-des-plaines-il--pma-p230003-s013) - [Abbott Molecular, Inc.: PMA supplement approved for Alinity m HR HPV Assay](/report/fdaapprovalpulse/abbott-molecular-inc-des-plaines-il--pma-p230003-s014) - [Baxter Healthcare Corporation: PMA supplement approved for PerClot® Polysaccharide Hemostatic System](/report/fdaapprovalpulse/baxter-healthcare-corporation-round-lake-il--pma-p210036-s008) - [Baxter Healthcare Corporation: PMA supplement approved for PerClot® Polysaccharide Hemostatic System](/report/fdaapprovalpulse/baxter-healthcare-corporation-round-lake-il--pma-p210036-s009) - [Baxter Healthcare Corporation: PMA supplement approved for PerClot® Polysaccharide Hemostatic System](/report/fdaapprovalpulse/baxter-healthcare-corporation-round-lake-il--pma-p210036-s007) - [Endotronix, Inc.: PMA supplement approved for Cordelia™ Pulmonary Artery Pressure Sensor System (CorPASS)](/report/fdaapprovalpulse/endotronix-inc-naperville-il--pma-p230040-s031) - [Tempus AI, Inc.: PMA supplement approved for xT CDx](/report/fdaapprovalpulse/tempus-ai-inc-chicago-il--pma-p210011-s002) - [Tempus AI, Inc.: PMA supplement approved for xT CDx](/report/fdaapprovalpulse/tempus-ai-inc-chicago-il--pma-p210011-s004) ## Indiana - [Biomet Manufacturing Corp: PMA supplement approved for Oxford Partial Knee System; Cementless Oxford™Partial Knee System](/report/fdaapprovalpulse/biomet-manufacturing-corp-warsaw-in--pma-p010014-s112) - [Depuy, Inc.: PMA supplement approved for Attune Revision Knee System](/report/fdaapprovalpulse/depuy-inc-warsaw-in--pma-p830055-s351) - [Depuy, Inc.: PMA supplement approved for ATTUNE Revision Knee System](/report/fdaapprovalpulse/depuy-inc-warsaw-in--pma-p830055-s360) - [Depuy, Inc.: PMA supplement approved for LCS® Total Knee System](/report/fdaapprovalpulse/depuy-inc-warsaw-in--pma-p830055-s367) ## Maryland - [Becton, Dickinson and Company: PMA supplement approved for BD Onclarity™ HPV Assay](/report/fdaapprovalpulse/becton-dickinson-and-company-sparks-md--pma-p160037-s028) - [Becton, Dickinson and Company: PMA supplement approved for BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 44](/report/fdaapprovalpulse/becton-dickinson-and-company-sparks-md--pma-p160037-s027) - [Dt Medtech, LLC: PMA supplement approved for Hintermann Series H3 Total Ankle Replacement System](/report/fdaapprovalpulse/dt-medtech-llc-towson-md--pma-p160036-s008) - [Life Technologies Corporation: PMA supplement approved for Oncomine™ Dx Express Test](/report/fdaapprovalpulse/life-technologies-corporation-frederick-md--pma-p240040-s005) - [Lung Bioengineering, Inc.: PMA approval for LungFX™ device](/report/fdaapprovalpulse/lung-bioengineering-inc-silver-spring-md--pma-p240033-orig) - [Lung Bioengineering, Inc.: PMA supplement approved for LungFX™ Device](/report/fdaapprovalpulse/lung-bioengineering-inc-silver-spring-md--pma-p240033-s001) - [Lung Bioengineering, Inc.: PMA supplement approved for LungFX™ Device](/report/fdaapprovalpulse/lung-bioengineering-inc-silver-spring-md--pma-p240033-s002) - [Personal Genome Diagnostics, Inc.: PMA approval for PGDx elio tissue complete CDx](/report/fdaapprovalpulse/personal-genome-diagnostics-inc-blatimore-md--pma-p250036-orig) - [Terumo Medical Corporation: PMA supplement approved for Angio Seal VIP Vascular Closure Device](/report/fdaapprovalpulse/terumo-medical-corporation-elkton-md--pma-p930038-s107) ## Massachusetts - [Abiomed, Inc.: PMA supplement approved for Impella CP with SmartAssist](/report/fdaapprovalpulse/abiomed-inc-danvers-ma--pma-p140003-s138) 1 [2](/hub/fdaapprovalpulse/records/2) [Browse FdaApprovalPulse by category and location](/hub/fdaapprovalpulse) · [Search and filter FdaApprovalPulse](/v/fdaapprovalpulse)