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).

• Advanced Medical Solutions Limited: PMA supplement approved for LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hern
• Croma-Pharma GmbH: PMA supplement approved for saypha® ChiQ™
• Croma-Pharma GmbH: PMA supplement approved for saypha® ChiQ™
• Ferrosan Meidcal Devices A/S: PMA supplement approved for SURGIFOAM® Absorbable Gelatin Sponge
• Insightec: PMA supplement approved for Exablate Model 4000 System
• Kardium, Inc.: PMA supplement approved for Globe® Catheter and Globe® Pulsed Field System
• Keri Medical SA: PMA supplement approved for TOUCH® CMC 1 Prosthesis
• Mainstay Medical Limited: PMA supplement approved for ReActiv8 Implantable Neurostimulation System
• Med-El Corp.: PMA supplement approved for MED-EL Cochlear Implant System
• Novocure, GmbH: PMA supplement approved for Novocure GmbH’s Optune Gio
• Novocure, GmbH: PMA supplement approved for Optune Gio
• Novocure, GmbH: PMA supplement approved for Optune Lua®
• Novocure, GmbH: PMA supplement approved for Optune Pax®
• OrbusNeich Medical (Shenzhen) Co., Ltd.: PMA supplement approved for Scoreflex NC Scoring PTCA Catheter
• Organox Limited: PMA supplement approved for OrganOx metra® System
• Organox Limited: PMA supplement approved for OrganOx metra® System
• Organox Limited: PMA supplement approved for OrganOx metra® System
• Perimeter Medical Imaging Ai, Inc.: PMA supplement approved for Claire™ OCT System
• Premia Spine, Ltd.: PMA supplement approved for TOPS™ System
• Proverum, Ltd.: PMA supplement approved for ProVee System for BPH
• Q-Med AB: PMA supplement approved for Restylane® Contour
• Q-Med AB: PMA supplement approved for Restylane® Contour
• QIAGEN GmbH: PMA supplement approved for QIAGEN therascreen® FGFR RGQ RT-PCR Kit
• Rayner Intraocular Lenses , Ltd.: PMA supplement approved for RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X
• Saluda Medical Pty, Ltd.: PMA supplement approved for CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application
• Saluda Medical Pty, Ltd.: PMA supplement approved for Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042)
• Seikagaku Corp.: PMA supplement approved for Gel-One
• Seikagaku Corp.: PMA supplement approved for SUPARTZ FX
• Stryker Leibinger GmbH & Co KG: PMA supplement approved for Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant
• Terumo Medical Corporation: PMA supplement approved for MISAGO(TM) RX Self-expanding Peripheral Stent
• Vascutek, Ltd.: PMA supplement approved for Thoraflex™ Hybrid

Arizona

• Bard Peripheral Vascular, Inc.: PMA approval for Liverty™ TIPS Stent Graft
• Bard Peripheral Vascular, Inc.: PMA supplement approved for LifeStent 5F Vascular Stent System
• Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA approval for VENTANA PTEN (SP218) RxDx Assay
• Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA supplement approved for VENTANA MET (SP44) RxDx Assay
• Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA supplement approved for VENTANA MMR RxDx Panel
• Ventana Medical Systems, Inc.: PMA supplement approved for HER2 Dual ISH DNA Probe Cocktail
• Ventana Medical Systems, Inc.: PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
• Ventana Medical Systems, Inc.: PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
• Ventana Medical Systems, Inc.: PMA supplement approved for VENTANA HER2 Dual ISH DNA Probe Cocktail
• Ventana Medical Systems: PMA supplement approved for VENTANA MMR RxDx Panel
• W. L. Gore & Associates, Inc.: PMA supplement approved for GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
• W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder
• W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® AAA Endoprosthesis
• W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis
• W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1
• W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
• W. L. Gore and Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® Conformable AAA Endoprosthesis
• W. L. Gore and Associates, Inc.: PMA supplement approved for GORE® EXCLUDER® Conformable AAA Endoprosthesis

California

• ABBOTT MEDICAL: PMA supplement approved for Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
• ABBOTT MEDICAL: PMA supplement approved for Assurity MRI / Endurity MRI Pacemakers
• ABBOTT MEDICAL: PMA supplement approved for Assurity, Assurity+, Endurity, Accent family of Pacemakers
• ABBOTT MEDICAL: PMA supplement approved for Aveir™ Leadless System
• ABBOTT MEDICAL: PMA supplement approved for Aveir VR (LSCD111); DR Delivery Catheter (LSCD201)
• ABBOTT MEDICAL: PMA supplement approved for Aveir VR Leadless System
• ABBOTT MEDICAL: PMA supplement approved for AVEIR VR Real-World Evidence Study
• ABBOTT MEDICAL: PMA supplement approved for Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+
• ABBOTT MEDICAL: PMA supplement approved for Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
• ABBOTT MEDICAL: PMA supplement approved for Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
• ABBOTT MEDICAL: PMA supplement approved for HeartMate 3™ Left Ventricular Assist System
• ABBOTT MEDICAL: PMA supplement approved for HeartMate 3™ Left Ventricular Assist System
• ABBOTT MEDICAL: PMA supplement approved for HeartMate 3™ Left Ventricular Assist System (LVAS)
• ABBOTT MEDICAL: PMA supplement approved for HeartMate II Left Ventricular Assist System
• ABBOTT MEDICAL: PMA supplement approved for HeartMate II Left Ventricular Assist System (LVAS)
• ABBOTT MEDICAL: PMA supplement approved for Microny family of Pacemakers
• ABBOTT MEDICAL: PMA supplement approved for Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra A
• ABBOTT MEDICAL: PMA supplement approved for The AVEIR Leadless Pacemaker (LP)
• ABBOTT MEDICAL: PMA supplement approved for UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isof
• ABBOTT MEDICAL: PMA supplement approved for UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isof
• Abbott Vascular, Inc.: PMA supplement approved for Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Clo
• Abbott: PMA supplement approved for CentriMag™ Circulatory Support System
• Acu Focus, Inc.: PMA supplement approved for IC-8 Apthera Intraocular Lens (IOL)
• Agilent Technologies, Inc.: PMA supplement approved for MAGE-A4 IHC 1F9 pharmDx
• Agilent Technologies, Inc.: PMA supplement approved for PD-L1 IHC 28-8 pharmDx
• Allergan: PMA supplement approved for Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive
• Allergan: PMA supplement approved for Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Impla
• Allergan: PMA supplement approved for SKINVIVE by JUVEDERM®
• Allergan: PMA supplement approved for Ultra, Ultra XC, Ultra Plus XC
• AutoGenomics, Inc.: PMA supplement approved for AvertD and AvertD Buccal Sample Collection Kit
• Balt USA, LLC: PMA supplement approved for SQUID Liquid Embolic Agent (LEA)
• Balt USA, LLC: PMA supplement approved for SQUID Liquid Embolic Agent (LEA)
• Biosense Webster, Inc.: PMA supplement approved for Dual Energy THERMOCOOL SMARTTOUCH SF™ System
• Biosense Webster, Inc.: PMA supplement approved for THERMOCOOL SMARTTOUCH® SF Catheter
• Biosense Webster, Inc.: PMA supplement approved for VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)
• Biosense Webster, Inc.: PMA supplement approved for VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System
• Boston Scientific Corp: PMA supplement approved for Celestia Implantable Pulse Generator, Celestia External Trial Stimulator
• Boston Scientific Corp: PMA supplement approved for Deep Brain Stimulation (DBS) Systems
• Boston Scientific Corp: PMA supplement approved for Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Syste
• Boston Scientific Corp: PMA supplement approved for Spinal Cord Stimulation (SCS)
• Boston Scientific Corp: PMA supplement approved for Vercise DBS Systems
• Boston Scientific Corp: PMA supplement approved for VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM
• Boston Scientific Corp: PMA supplement approved for Vercise Genus DBS Systems; Vercise Gevia DBS Systems
• Boston Scientific Corp: PMA supplement approved for WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS
• Carl Zeiss Meditec, Inc.: PMA supplement approved for MEL 90 Excimer Laser
• Carl Zeiss Meditec, Inc.: PMA supplement approved for VISUMAX 800 Femtosecond Laser
• Channel Medsystems, Inc.: PMA supplement approved for Cerene® Cryotherapy Device
• Edwards Lifesciences, LLC: PMA approval for Autus Size-Adjustable Valve
• Edwards Lifesciences, LLC: PMA supplement approved for Edwards Crimper: 9600CR
• Edwards Lifesciences, LLC: PMA supplement approved for Edwards EVOQUE Tricuspid Valve Replacement System
• Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29
• Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent
• Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Ultra™ RESILIA Transcatheter Heart Valve
• Edwards Lifesciences, LLC: PMA supplement approved for EVOQUE Tricuspid Valve Replacement System
• Edwards Lifesciences, LLC: PMA supplement approved for EVOQUE Tricuspid Valve Replacement System
• Edwards Lifesciences, LLC: PMA supplement approved for INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve
• Edwards Lifesciences, LLC: PMA supplement approved for PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System
• Edwards Lifesciences, LLC: PMA supplement approved for PASCAL Precision Transcatheter Valve Repair System
• Edwards Lifesciences, LLC: PMA supplement approved for PASCAL Precision Transcatheter Valve Repair System
• Edwards Lifesciences, LLC: PMA supplement approved for TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33
• Endologix, LLC: PMA supplement approved for Alto Abdominal Stent Graft System
• Ev3 Neurovascular: PMA supplement approved for Onyx™ Liquid Embolic System (LES)
• Ev3 Neurovascular: PMA supplement approved for Onyx™ Liquid Embolic System (Onyx™ LES)
• Farapulse, Inc.: PMA supplement approved for FARAPULSE™ Pulsed Field Ablation System
• Farapulse, Inc.: PMA supplement approved for FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTA
• Farapulse, Inc.: PMA supplement approved for FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FA
• Freenome, LLC: PMA approval for SimpleScreen™ CRC
• Guardant Health, Inc.: PMA approval for Guardant360® Liquid CDx
• Guardant Health, Inc.: PMA supplement approved for Guardant360 CDx
• Guardant Health, Inc.: PMA supplement approved for Guardant360 CDx
• Guardant Health, Inc.: PMA supplement approved for Guardant360® CDx
• Guardant Health, Inc.: PMA supplement approved for Guardant360® CDx
• Guardant Health, Inc.: PMA supplement approved for Guardant360® CDx
• Guardant Health, Inc.: PMA supplement approved for Shield
• Illumina, Inc.: PMA supplement approved for TruSight Oncology Comprehensive
• Illumina, Inc.: PMA supplement approved for TruSight Oncology Comprehensive
• Irvine Biomedical, Inc.: PMA supplement approved for Ampere Generator
• Irvine Biomedical, Inc.: PMA supplement approved for Ampere Generator
• Irvine Biomedical,Inc.(Ibi): PMA supplement approved for Ampere Generator
• JenaValve Technology, Inc.: PMA supplement approved for Trilogy Transcatheter Heart Valve System
• JenaValve Technology, Inc.: PMA supplement approved for Trilogy Transcatheter Heart Valve System
• Johnson & Johnson Surgical Vision, Inc.: PMA supplement approved for TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600)
• MedAlliance, LLC: PMA approval for SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
• Medtronic Minimed, Inc.: PMA supplement approved for MiniMed 780G System
• Medtronic Minimed, Inc.: PMA supplement approved for MiniMed 780G System
• Medtronic Minimed, Inc.: PMA supplement approved for Simplera Sync Sensor
• Medtronic, Inc.: PMA supplement approved for Symplicity Spyral™ Renal Denervation System
• Medtronic, Inc.: PMA supplement approved for Symplicity Spyral™ Renal Denervation System
• Mentor Corp.: PMA supplement approved for MENTOR™ MemoryGel™ Breast Implants
• Mentor Corp.: PMA supplement approved for MENTOR™ MemoryGel™ Enhance Breast Implants
• Mentor Worldwide, LLC: PMA supplement approved for MENTOR™ MemoryShape™ Breast Implants
• Microcube, LLC: PMA supplement approved for Minitouch 3.8 Era System (Minitouch System)
• Motiva USA, LLC: PMA supplement approved for Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk R
• Motiva USA, LLC: PMA supplement approved for Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants
• NeuroPace, Inc.: PMA supplement approved for NeuroPace® RNS® System
• NeuroPace, Inc.: PMA supplement approved for NeuroPace® RNS® System
• Neuros Medical, Inc.: PMA supplement approved for Altius® Direct Electrical Nerve Stimulation System
• Neuspera Medical, Inc.: PMA supplement approved for Neuspera Sacral Neuromodulation (SNM) System
• Nevro Corporation: PMA supplement approved for HFX Dynamis System
• Pulmonx Corporation: PMA supplement approved for Zephyr Endobronchial Valve System
• Recor Medical, Inc.: PMA supplement approved for Paradise™ Ultrasound Renal Denervation System (Paradise System)
• Renata Medical, Inc.: PMA supplement approved for Minima Pro Stent System
• Renata Medical, Inc.: PMA supplement approved for Minima Stent System; Minima Pro Stent System
• Roche Molecular Systems, Inc.: PMA supplement approved for cobas HPV
• Rxsight, Inc.: PMA supplement approved for RxSight Light Adjustable Lens and Light Delivery Device
• Rxsight, Inc.: PMA supplement approved for RxSight Light Adjustable Lens; Light Delivery Device
• Rxsight, Inc.: PMA supplement approved for RxSight Light Adjustable Lens; Light Delivery Device
• Shockwave Medical, Inc.: PMA supplement approved for Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Ae
• Spineart USA, Inc.: PMA approval for BAGUERA®C Cervical Disc Prosthesis
• Spineart USA, Inc.: PMA supplement approved for BAGUERA®C Cervical Disc Prosthesis

Colorado

• Hepquant, LLC: PMA approval for HepQuant SHUNT® Liver Diagnostic Test
• Spectranetics Corp.: PMA supplement approved for ELCA Coronary Laser Atherectomy Catheters
• Synergy Spine Solutions, Inc.: PMA supplement approved for Synergy Disc
• Xvivo Perfusion, Inc.: PMA supplement approved for XPS™ with Steen Solution™ Perfusate

Connecticut

• Defibtech, LLC: PMA supplement approved for Defibtech Automated External Defibrillator (AED) Systems
• Defibtech, LLC: PMA supplement approved for Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline V
• Defibtech, LLC: PMA supplement approved for Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AED
• Defibtech, LLC: PMA supplement approved for Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, L

Florida

• Biomet Microfixation, Inc.: PMA supplement approved for Total Temporomandibular Joint Replacement System
• Cerenovus, Inc.: PMA supplement approved for TRUFILL n-BCA Liquid Embolic System
• Cordis US Corporation: PMA supplement approved for Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Ven
• Cordis US Corporation: PMA supplement approved for Exoseal Vascular Closure Device
• Cordis US Corporation: PMA supplement approved for PRECISE PRO RX Nitinol Stent System
• Lenstec, Inc.: PMA supplement approved for ClearView™ HD intraocular lens (IOL)

Georgia

• ABBOTT MEDICAL: PMA supplement approved for CardioMEMS HF System
• ABBOTT MEDICAL: PMA supplement approved for CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Appl
• Artivion, Inc.: PMA approval for AMDS Hybrid Prosthesis
• Cryolife, Inc.: PMA supplement approved for BioGlue® Surgical Adhesive

Illinois

• Abbott Molecular, Inc.: PMA supplement approved for Alinity m HR HPV
• Abbott Molecular, Inc.: PMA supplement approved for Alinity m HR HPV
• Abbott Molecular, Inc.: PMA supplement approved for Alinity m HR HPV Assay
• Baxter Healthcare Corporation: PMA supplement approved for PerClot® Polysaccharide Hemostatic System
• Baxter Healthcare Corporation: PMA supplement approved for PerClot® Polysaccharide Hemostatic System
• Baxter Healthcare Corporation: PMA supplement approved for PerClot® Polysaccharide Hemostatic System
• Endotronix, Inc.: PMA supplement approved for Cordelia™ Pulmonary Artery Pressure Sensor System (CorPASS)
• Tempus AI, Inc.: PMA supplement approved for xT CDx
• Tempus AI, Inc.: PMA supplement approved for xT CDx

Indiana

• Biomet Manufacturing Corp: PMA supplement approved for Oxford Partial Knee System; Cementless Oxford™Partial Knee System
• Depuy, Inc.: PMA supplement approved for Attune Revision Knee System
• Depuy, Inc.: PMA supplement approved for ATTUNE Revision Knee System
• Depuy, Inc.: PMA supplement approved for LCS® Total Knee System

Maryland

• Becton, Dickinson and Company: PMA supplement approved for BD Onclarity™ HPV Assay
• Becton, Dickinson and Company: PMA supplement approved for BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 44
• Dt Medtech, LLC: PMA supplement approved for Hintermann Series H3 Total Ankle Replacement System
• Life Technologies Corporation: PMA supplement approved for Oncomine™ Dx Express Test
• Lung Bioengineering, Inc.: PMA approval for LungFX™ device
• Lung Bioengineering, Inc.: PMA supplement approved for LungFX™ Device
• Lung Bioengineering, Inc.: PMA supplement approved for LungFX™ Device
• Personal Genome Diagnostics, Inc.: PMA approval for PGDx elio tissue complete CDx
• Terumo Medical Corporation: PMA supplement approved for Angio Seal VIP Vascular Closure Device

Massachusetts

• Abiomed, Inc.: PMA supplement approved for Impella CP with SmartAssist

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