- [Home](/) › - [FdaApprovalPulse](/v/fdaapprovalpulse) › - [Hubs](/hub/fdaapprovalpulse) › - [All record reports](/hub/fdaapprovalpulse/records) › - Page 2 # FdaApprovalPulse: all 386 record reports, page 2 of 2 Every FdaApprovalPulse record report, 200 per page, grouped by state. Records 201 to 386: Allurion Technologies, Inc.: PMA supplement approved for Allurion™ Gastric Balloon System to Endospan , Ltd.: PMA supplement approved for NEXUS Aortic Arch Stent Graft System. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). [1](/hub/fdaapprovalpulse/records) 2 ## Massachusetts - [Allurion Technologies, Inc.: PMA supplement approved for Allurion™ Gastric Balloon System](/report/fdaapprovalpulse/allurion-technologies-inc-natick-ma--pma-p250023-s002) - [Allurion Technologies, Inc.: PMA supplement approved for Allurion™ Gastric Balloon System](/report/fdaapprovalpulse/allurion-technologies-inc-natick-ma--pma-p250023-s001) - [Beaver Visitec International, Inc.: PMA supplement approved for FINEVISION HP Trifocal IOLs](/report/fdaapprovalpulse/beaver-visitec-international-inc-waltham-ma--pma-p240038-s003) - [Boston Scientific Corp: PMA supplement approved for AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™](/report/fdaapprovalpulse/boston-scientific-corp-marlboro-ma--pma-n970012-s211) - [Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System](/report/fdaapprovalpulse/boston-scientific-corporation-marlborough-ma--pma-p180046-s113) - [Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System](/report/fdaapprovalpulse/boston-scientific-corporation-marlborough-ma--pma-p190006-s113) - [Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System](/report/fdaapprovalpulse/boston-scientific-corporation-marlborough-ma--pma-p190006-s110) - [Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System](/report/fdaapprovalpulse/boston-scientific-corporation-marlborough-ma--pma-p180046-s110) - [Boston Scientific Corporation: PMA supplement approved for TheraSphere](/report/fdaapprovalpulse/boston-scientific-corporation-marborough-ma--pma-p200029-s014) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s069) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s064) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s065) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s067) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx (F1CDx)](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s062) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx (F1CDx)](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s057) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx (F1CDx)](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s060) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne Liquid CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p190032-s029) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne Liquid CDx (F1 Liquid CDx)](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p190032-s030) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne® CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p170019-s059) - [Foundation Medicine, Inc.: PMA supplement approved for FoundationOne®Liquid CDx](/report/fdaapprovalpulse/foundation-medicine-inc-boston-ma--pma-p190032-s025) - [Instylla, Inc.: PMA supplement approved for Embrace(TM) Hydrogel Embolic System](/report/fdaapprovalpulse/instylla-inc-bedford-ma--pma-p250003-s008) - [Instylla, Inc.: PMA supplement approved for Embrace(TM) Hydrogel Embolic System](/report/fdaapprovalpulse/instylla-inc-bedford-ma--pma-p250003-s010) - [Instylla, Inc.: PMA supplement approved for Embrace® Hydrogel Embolic System](/report/fdaapprovalpulse/instylla-inc-bedford-ma--pma-p250003-s011) - [LeMaitre Vascular, Inc.: PMA supplement approved for Artegraft Collagen Vascular Graft](/report/fdaapprovalpulse/lemaitre-vascular-inc-burlington-ma--pma-n16837-s039) - [Pramand, LLC: PMA supplement approved for CraniSeal™ Dural Sealant](/report/fdaapprovalpulse/pramand-llc-bedford-ma--pma-p220014-s013) - [Pramand, LLC: PMA supplement approved for CraniSeal Dural Sealant](/report/fdaapprovalpulse/pramand-llc-bedford-ma--pma-p220014-s012) - [Pramand, LLC: PMA supplement approved for SpineSeal™ Spine Sealant](/report/fdaapprovalpulse/pramand-llc-bedford-ma--pma-p240027-s007) - [Pramand, LLC: PMA supplement approved for SpineSeal Spine Sealant](/report/fdaapprovalpulse/pramand-llc-bedford-ma--pma-p240027-s006) - [Rejoni, Inc.: PMA approval for Juveena Hydrogel System](/report/fdaapprovalpulse/rejoni-inc-bedford-ma--pma-p250051-orig) - [Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)](/report/fdaapprovalpulse/siemens-healthcare-diagnostics-inc-east-walpole-ma--pma-p930036-s026) - [Smith and Nephew, Inc.: PMA supplement approved for Agili-C](/report/fdaapprovalpulse/smith-and-nephew-inc-andover-ma--pma-p210034-s001) - [TransMedics, Inc.: PMA supplement approved for Organ Care System (OCS™) Liver](/report/fdaapprovalpulse/transmedics-inc-andover-ma--pma-p200031-s013) - [TransMedics, Inc.: PMA supplement approved for Organ Care System (OCS™) Lung System](/report/fdaapprovalpulse/transmedics-inc-andover-ma--pma-p160013-s021) - [ZOLL Medical Corporation: PMA supplement approved for AED 3 Defibrillator with Uni-Padz](/report/fdaapprovalpulse/zoll-medical-corporation-chelsmford-ma--pma-p160015-s029) - [ZOLL Medical Corporation: PMA supplement approved for AED 3; CPR Uni-Padz](/report/fdaapprovalpulse/zoll-medical-corporation-chelsmford-ma--pma-p160015-s028) - [ZOLL Medical Corporation: PMA supplement approved for CPR Uni-padz Electrode](/report/fdaapprovalpulse/zoll-medical-corporation-chelsmford-ma--pma-p160022-s051) ## Minnesota - [ABBOTT MEDICAL: PMA supplement approved for Ampere Generator](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p110016-s095) - [ABBOTT MEDICAL: PMA supplement approved for Amplatzer™ Amulet™ Left Atrial Appendage Occluder](/report/fdaapprovalpulse/abbott-medical-st-paul-mn--pma-p200049-s021) - [ABBOTT MEDICAL: PMA supplement approved for Current™ PFA Generator – TactiFlex Duo](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p250022-s005) - [ABBOTT MEDICAL: PMA supplement approved for Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves](/report/fdaapprovalpulse/abbott-medical-st-paul-mn--pma-p040021-s061) - [ABBOTT MEDICAL: PMA supplement approved for Navitor™ TAVI System with Vision Technology](/report/fdaapprovalpulse/abbott-medical-st-paul-mn--pma-p190023-s029) - [ABBOTT MEDICAL: PMA supplement approved for Navitor Transcatheter Aortic Valve Implantation System](/report/fdaapprovalpulse/abbott-medical-st-paul-mn--pma-p190023-s034) - [ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Ablation Catheter, Sensor Enabled™](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p220013-s034) - [ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quart](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p220013-s030) - [ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p220013-s028) - [ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Sensor Enabled™ Ablation Catheter](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p220013-s022) - [ABBOTT MEDICAL: PMA supplement approved for TactiSys Quartz Equipment; Ampere Generator](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p220013-s033) - [ABBOTT MEDICAL: PMA supplement approved for Volt™ PFA System](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p250022-s002) - [ABBOTT MEDICAL: PMA supplement approved for Volt™ PFA System](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p250022-s006) - [Boston Scientific Corp: PMA supplement approved for ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2](/report/fdaapprovalpulse/boston-scientific-corp-st-paul-mn--pma-n970003-s307) - [Boston Scientific Corp: PMA supplement approved for COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, V](/report/fdaapprovalpulse/boston-scientific-corp-st-paul-mn--pma-p010012-s607) - [Boston Scientific Corp: PMA supplement approved for ROTAPRO™ Rotational Atherectomy Systems](/report/fdaapprovalpulse/boston-scientific-corp-maple-grove-mn--pma-p900056-s226) - [Boston Scientific Corp: PMA supplement approved for Tachy Pulse Generators](/report/fdaapprovalpulse/boston-scientific-corp-st-paul-mn--pma-p010012-s612) - [Boston Scientific Corp: PMA supplement approved for WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro](/report/fdaapprovalpulse/boston-scientific-corp-maple-grove-mn--pma-p130013-s086) - [Boston Scientific Corp: PMA supplement approved for WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro](/report/fdaapprovalpulse/boston-scientific-corp-maple-grove-mn--pma-p130013-s084) - [Boston Scientific Corporation: PMA supplement approved for EMBLEM S-ICD](/report/fdaapprovalpulse/boston-scientific-corporation-st-paul-mn--pma-p110042-s211) - [Boston Scientific Corporation: PMA supplement approved for EMBLEM™ S-ICD Electrode (Lead) Model 3501](/report/fdaapprovalpulse/boston-scientific-corporation-st-paul-mn--pma-p110042-s210) - [Boston Scientific Corporation: PMA supplement approved for POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREE](/report/fdaapprovalpulse/boston-scientific-corporation-st-paul-mn--pma-p220032-s012) - [Boston Scientific Corporation: PMA supplement approved for Ranger™ Paclitaxel-Coated Balloon Catheter](/report/fdaapprovalpulse/boston-scientific-corporation-maple-grove-mn--pma-p190019-s043) - [Boston Scientific Corporation: PMA supplement approved for Ranger™ Paclitaxel-Coated PTA Balloon Catheter](/report/fdaapprovalpulse/boston-scientific-corporation-maple-grove-mn--pma-p190019-s040) - [Coloplast Corp.: PMA supplement approved for Titan Inflatable Penile Prosthesis (IPP)](/report/fdaapprovalpulse/coloplast-corp-plymouth-mn--pma-p000006-s072) - [DiaSorin, Inc.: PMA approval for LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus](/report/fdaapprovalpulse/diasorin-inc-stillwater-mn--pma-p250039-orig) - [DiaSorin, Inc.: PMA supplement approved for LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus](/report/fdaapprovalpulse/diasorin-inc-stillwater-mn--pma-p220034-s010) - [DiaSorin, Inc.: PMA supplement approved for LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFE](/report/fdaapprovalpulse/diasorin-inc-stillwater-mn--pma-p180047-s045) - [DiaSorin, Inc.: PMA supplement approved for LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON Qua](/report/fdaapprovalpulse/diasorin-inc-stillwater-mn--pma-p180047-s043) - [Envoy Medical Corporation: PMA supplement approved for Esteem®](/report/fdaapprovalpulse/envoy-medical-corporation-white-bear-lake-mn--pma-p090018-s042) - [Guidant Corp.: PMA supplement approved for INVIVE, INTUA, VISIONIST, VALITUDE](/report/fdaapprovalpulse/guidant-corp-st-paul-mn--pma-p030005-s253) - [Inspire Medical Systems: PMA supplement approved for INSPIRE II UPPER AIRWAY STIMULATOR](/report/fdaapprovalpulse/inspire-medical-systems-maple-grove-mn--pma-p130008-s123) - [Inspire Medical Systems: PMA supplement approved for Model 3150 Implantable Pulse Generator (IPG)](/report/fdaapprovalpulse/inspire-medical-systems-maple-grove-mn--pma-p130008-s140) - [Inspire Medical Systems: PMA supplement approved for Model 4063 Inspire Stimulation Lead](/report/fdaapprovalpulse/inspire-medical-systems-maple-grove-mn--pma-p130008-s136) - [Lutonix: PMA supplement approved for Lutonix™ 018 Drug Coated Balloon PTA Catheter](/report/fdaapprovalpulse/lutonix-new-hope-mn--pma-p170003-s029) - [Lutonix: PMA supplement approved for Lutonix™ 035 Drug Coated Balloon Catheter](/report/fdaapprovalpulse/lutonix-new-hope-mn--pma-p130024-s045) - [Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava](/report/fdaapprovalpulse/medtronic-cardiac-rhythm-disease-management-mounds-view-mn--pma-p010031-s922) - [Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVB](/report/fdaapprovalpulse/medtronic-cardiac-rhythm-disease-management-mounds-view-mn--pma-p980016-s955) - [Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for SelectSecure Lead Model 3830](/report/fdaapprovalpulse/medtronic-cardiac-rhythm-disease-management-mounds-view-mn--pma-p030036-s158) - [Medtronic Cryocath, LP: PMA supplement approved for Stop AF First](/report/fdaapprovalpulse/medtronic-cryocath-lp-mounds-view-mn--pma-p100010-s152) - [Medtronic Cryocath, LP: PMA supplement approved for STOP Persistent AF](/report/fdaapprovalpulse/medtronic-cryocath-lp-mounds-view-mn--pma-p100010-s154) - [Medtronic, Inc.: PMA supplement approved for Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™](/report/fdaapprovalpulse/medtronic-inc-minneapolis-mn--pma-p960009-s542) - [Medtronic, Inc.: PMA supplement approved for Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™](/report/fdaapprovalpulse/medtronic-inc-minneapolis-mn--pma-p960009-s531) - [Medtronic, Inc.: PMA supplement approved for Affera Ablation System](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s022) - [Medtronic, Inc.: PMA supplement approved for Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astr](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p980035-s836) - [Medtronic, Inc.: PMA supplement approved for Aurora EV ICD DVEA3E4](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p220012-s069) - [Medtronic, Inc.: PMA supplement approved for CareLink SmartSync™ Adapta™ Versa™ Sensia™ Application (D00U014)](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p980035-s835) - [Medtronic, Inc.: PMA supplement approved for CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p890003-s485) - [Medtronic, Inc.: PMA supplement approved for HexaGen RF Generator Software and Remote](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s026) - [Medtronic, Inc.: PMA supplement approved for Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX T](/report/fdaapprovalpulse/medtronic-inc-miinneapolis-mn--pma-p130021-s185) - [Medtronic, Inc.: PMA supplement approved for Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmo](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p140017-s035) - [Medtronic, Inc.: PMA supplement approved for Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Mic](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p150033-s224) - [Medtronic, Inc.: PMA supplement approved for Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p010015-s583) - [Medtronic, Inc.: PMA supplement approved for Sphere-9 Catheter™ and Affera™ Ablation System](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s028) - [Medtronic, Inc.: PMA supplement approved for Sphere-9 Catheter and Affera Ablation System](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s031) - [Medtronic, Inc.: PMA supplement approved for Sphere-9 Catheter and Affera Ablation System](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s025) - [Medtronic: PMA supplement approved for HeartWare™ HVAD™ System](/report/fdaapprovalpulse/medtronic-mounds-view-mn--pma-p100047-s240) - [Medtronic: PMA supplement approved for HeartWare® HVAD System](/report/fdaapprovalpulse/medtronic-mounds-view-mn--pma-p100047-s241) - [Medtronic: PMA supplement approved for HeartWare® Ventricular Assist System](/report/fdaapprovalpulse/medtronic-mounds-view-mn--pma-p100047-s239) - [St Jude Medical: PMA supplement approved for Ampere Generator](/report/fdaapprovalpulse/st-jude-medical-minnetonka-mn--pma-p960016-s094) - [St Jude Medical: PMA supplement approved for TactiSys Quartz Equipment; Ampere Generator](/report/fdaapprovalpulse/st-jude-medical-st-paul-mn--pma-p130026-s102) ## Missouri - [Geneoscopy, Inc.: PMA supplement approved for ColoSense®](/report/fdaapprovalpulse/geneoscopy-inc-st-louis-mo--pma-p230001-s014) - [Geneoscopy, Inc.: PMA supplement approved for ColoSense®](/report/fdaapprovalpulse/geneoscopy-inc-st-louis-mo--pma-p230001-s012) - [Medibeacon, Inc.: PMA supplement approved for MediBeacon Transdermal GFR System](/report/fdaapprovalpulse/medibeacon-inc-st-louis-mo--pma-p230019-s005) - [Medibeacon, Inc.: PMA supplement approved for MediBeacon® Transdermal GFR Measurement System (TGFR)](/report/fdaapprovalpulse/medibeacon-inc-st-louis-mo--pma-p230019-s002) - [Stereotaxis, Inc.: PMA supplement approved for MAGiC Ablation Catheter](/report/fdaapprovalpulse/stereotaxis-inc-saint-louis-mo--pma-p240014-s001) ## New Hampshire - [Atrium Medical Corp.: PMA supplement approved for iCast Covered Stent System](/report/fdaapprovalpulse/atrium-medical-corp-hudson-nh--pma-p120003-s007) ## New Jersey - [ETHICON, Inc.: PMA supplement approved for ETHIZIA™ Hemostatic Patch](/report/fdaapprovalpulse/ethicon-inc-raritan-nj--pma-p240035-s004) - [ETHICON, Inc.: PMA supplement approved for ETHIZIA Hemostatic Patch](/report/fdaapprovalpulse/ethicon-inc-raritan-nj--pma-p240035-s002) - [ETHICON, Inc.: PMA supplement approved for SURGICELTM POWDER Absorbable Hemostatic Powder](/report/fdaapprovalpulse/ethicon-inc-raritan-nj--pma-n12159-s129) - [Impulse Dynamics (Usa), Inc.: PMA supplement approved for OPTIMIZER Smart System](/report/fdaapprovalpulse/impulse-dynamics-usa-inc-marlton-nj--pma-p180036-s044) ## New York - [Bausch & Lomb, Inc.: PMA supplement approved for enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic](/report/fdaapprovalpulse/bausch-and-lomb-inc-rochester-ny--pma-p240005-s005) - [NuMED, Inc.: PMA supplement approved for CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered](/report/fdaapprovalpulse/numed-inc-hopkinton-ny--pma-p150028-s007) - [Siemens Healthcare Diagnostics, Inc.: PMA approval for Atellica IM free PSA II (fPSAII)](/report/fdaapprovalpulse/siemens-healthcare-diagnostics-inc-tarrytown-ny--pma-p250026-orig) - [Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for Atellica IM Total PSA II (tPSAII)](/report/fdaapprovalpulse/siemens-healthcare-diagnostics-inc-tarrytown-ny--pma-p240021-s001) ## North Carolina - [Merz North America, Inc.: PMA approval for Belotero Volume (+) Lidocaine](/report/fdaapprovalpulse/merz-north-america-inc-raleigh-nc--pma-p250020-orig) - [Merz North America, Inc.: PMA approval for Belotero® Intense (+) Lidocaine](/report/fdaapprovalpulse/merz-north-america-inc-raleigh-nc--pma-p250016-orig) - [Merz North America, Inc.: PMA supplement approved for Belotero® Intense (+) Lidocaine](/report/fdaapprovalpulse/merz-north-america-inc-raleigh-nc--pma-p250016-s004) ## Ohio - [AtriCure, Inc.: PMA supplement approved for EPi-Sense and EPi-Sense ST Guided Coagulation System](/report/fdaapprovalpulse/atricure-inc-mason-oh--pma-p200002-s014) - [AtriCure, Inc.: PMA supplement approved for Synergy Ablation System](/report/fdaapprovalpulse/atricure-inc-mason-oh--pma-p100046-s020) - [Cleveland Diagnostics, Inc.: PMA supplement approved for IsoPSA® Assay](/report/fdaapprovalpulse/cleveland-diagnostics-inc-cleveland-oh--pma-p200048-s001) ## Oregon - [Biotronik Nro, Inc.: PMA supplement approved for Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Re](/report/fdaapprovalpulse/biotronik-nro-inc-lake-oswego-or--pma-p210037-s012) - [Biotronik, Inc.: PMA supplement approved for Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura D](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p000009-s132) - [Biotronik, Inc.: PMA supplement approved for Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura H](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p050023-s213) - [Biotronik, Inc.: PMA supplement approved for Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura V](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p980023-s149) - [Biotronik, Inc.: PMA supplement approved for Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p980023-s146) - [Biotronik, Inc.: PMA supplement approved for BIOexpress](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p050023-s209) - [Biotronik, Inc.: PMA supplement approved for BIOexpress](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p000009-s128) - [Biotronik, Inc.: PMA supplement approved for BIOexpress](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p070008-s177) - [Biotronik, Inc.: PMA supplement approved for BIOexpress](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p950037-s289) - [Biotronik, Inc.: PMA supplement approved for Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evi](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p950037-s279) - [Biotronik, Inc.: PMA supplement approved for Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evi](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p950037-s296) - [Biotronik, Inc.: PMA supplement approved for Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enit](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p070008-s172) - [Biotronik, Inc.: PMA supplement approved for Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140;](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p070008-s181) - [Biotronik, Inc.: PMA supplement approved for Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 4](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p050023-s204) - [Biotronik, Inc.: PMA supplement approved for Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p000009-s124) - [Biotronik, Inc.: PMA supplement approved for Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p980023-s140) - [Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p070008-s179) - [Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aur](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p000009-s130) - [Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aur](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p050023-s211) - [Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky D](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p950037-s291) ## Pennsylvania - [Centinel Spine, LLC: PMA supplement approved for prodisc® C Nova](/report/fdaapprovalpulse/centinel-spine-llc-west-chester-pa--pma-p070001-s031) - [Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System](/report/fdaapprovalpulse/lungpacer-medical-usa-inc-exton-pa--pma-p240012-s008) - [Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System](/report/fdaapprovalpulse/lungpacer-medical-usa-inc-exton-pa--pma-p240012-s006) - [Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System](/report/fdaapprovalpulse/lungpacer-medical-usa-inc-exton-pa--pma-p240012-s007) - [Siemens Medical Solutions USA, Inc.: PMA supplement approved for MAMMOMAT B.brilliant with Tomosynthesis Option](/report/fdaapprovalpulse/siemens-medical-solutions-usa-inc-mavern-pa--pma-p140011-s009) - [Tiger Aesthetics Medical, LLC: PMA supplement approved for SANAE®](/report/fdaapprovalpulse/tiger-aesthetics-medical-llc-conshohocken-pa--pma-p020012-s051) - [Zoll Manufacturing Corporation: PMA supplement approved for LifeVest® Wearable Defibrillator](/report/fdaapprovalpulse/zoll-manufacturing-corporation-pittsburgh-pa--pma-p010030-s201) ## Tennessee - [Cyndrx, LLC: PMA approval for AbsorbaSeal 5.6.7F Vascular Closure Device](/report/fdaapprovalpulse/cyndrx-llc-brentwood-tn--pma-p230038-orig) - [Lynch Biologics, LLC: PMA supplement approved for GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (](/report/fdaapprovalpulse/lynch-biologics-llc-franklin-tn--pma-p040013-s033) - [Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for Infuse™ Bone Graft](/report/fdaapprovalpulse/medtronic-sofamor-danek-usa-inc-memphis-tn--pma-p000054-s078) - [Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for INFUSE BONE GRAFT](/report/fdaapprovalpulse/medtronic-sofamor-danek-usa-inc-memphis-tn--pma-p000054-s075) - [Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE](/report/fdaapprovalpulse/medtronic-sofamor-danek-usa-inc-memphis-tn--pma-p000058-s095) - [Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for Infuse TM Bone Graft/Medtronic lnterbody Fusion Device](/report/fdaapprovalpulse/medtronic-sofamor-danek-usa-inc-memphis-tn--pma-p000058-s099) - [Medtronic, Inc.: PMA supplement approved for Infuse™ Bone Graft](/report/fdaapprovalpulse/medtronic-inc-memphis-tn--pma-p050053-s069) - [Medtronic, Inc.: PMA supplement approved for INFUSE BONE GRAFT](/report/fdaapprovalpulse/medtronic-inc-memphis-tn--pma-p050053-s066) ## Texas - [ABBOTT MEDICAL: PMA supplement approved for Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p140009-s133) - [ABBOTT MEDICAL: PMA supplement approved for Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p150004-s095) - [ABBOTT MEDICAL: PMA supplement approved for Infinity DBS IPG](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p140009-s139) - [ABBOTT MEDICAL: PMA supplement approved for Proclaim DRG IPG](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p150004-s100) - [ABBOTT MEDICAL: PMA supplement approved for Proclaim family of SCS IPG](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p010032-s260) - [ABBOTT MEDICAL: PMA supplement approved for Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead Extensions](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p010032-s251) - [ABBOTT MEDICAL: PMA supplement approved for Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)](/report/fdaapprovalpulse/abbott-medical-plano-tx--pma-p010032-s254) - [Alcon Laboratories, LLC: PMA supplement approved for Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delive](/report/fdaapprovalpulse/alcon-laboratories-llc-fort-worth-tx--pma-p190018-s051) - [Alcon Laboratories, LLC: PMA supplement approved for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)](/report/fdaapprovalpulse/alcon-laboratories-llc-fort-worth-tx--pma-p190018-s046) - [Alcon Laboratories: PMA supplement approved for VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.](/report/fdaapprovalpulse/alcon-laboratories-fort-worth-tx--pma-p840064-s092) - [Alcon Research, Ltd.: PMA supplement approved for PROVISC Ophthalmic Viscosurgical Device](/report/fdaapprovalpulse/alcon-research-ltd-fort-worth-tx--pma-p890047-s070) - [Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric VAD](/report/fdaapprovalpulse/berlin-heart-inc-the-woodlands-tx--pma-p160035-s056) - [Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric Ventricular Assist Device](/report/fdaapprovalpulse/berlin-heart-inc-the-woodlands-tx--pma-p160035-s057) - [Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric Ventricular Assist Device](/report/fdaapprovalpulse/berlin-heart-inc-the-woodlands-tx--pma-p160035-s058) - [LivaNova USA, Inc.: PMA supplement approved for aura6000™ system](/report/fdaapprovalpulse/livanova-usa-inc-houston-tx--pma-p250013-s002) - [LivaNova USA, Inc.: PMA supplement approved for VNS Therapy System](/report/fdaapprovalpulse/livanova-usa-inc-houston-tx--pma-p970003-s249) - [LivaNova USA, Inc.: PMA supplement approved for VNS Therapy® System](/report/fdaapprovalpulse/livanova-usa-inc-houston-tx--pma-p970003-s254) - [Natera, Inc.: PMA approval for Signatera™ CDx](/report/fdaapprovalpulse/natera-inc-austin-tx--pma-p260004-orig) ## Utah - [Bunnell, Inc.: PMA supplement approved for LifePulse® High Frequency Ventilator](/report/fdaapprovalpulse/bunnell-inc-salt-lake-city-ut--pma-p850064-s056) ## Virginia - [Dilon Technologies, Inc.: PMA supplement approved for HEMOBLAST™ Bellows](/report/fdaapprovalpulse/dilon-technologies-inc-newport-news-va--pma-p170012-s032) - [Theragen, Inc.: PMA supplement approved for ActaStim-S](/report/fdaapprovalpulse/theragen-inc-manassas-va--pma-p190030-s004) ## Washington - [Gyrus Acmi, Inc.: PMA supplement approved for Spiration® Valve System](/report/fdaapprovalpulse/gyrus-acmi-inc-redmond-wa--pma-p180007-s016) - [Philips Medical Systems, Inc.: PMA supplement approved for HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator](/report/fdaapprovalpulse/philips-medical-systems-inc-bothell-wa--pma-p160028-s007) - [Philips Medical Systems: PMA supplement approved for HeartStart FRx Defibrillator (861304)](/report/fdaapprovalpulse/philips-medical-systems-bothell-wa--pma-p180028-s019) - [Physio-Control, Inc.: PMA supplement approved for LIFEPAK® 15 monitor/defibrillator](/report/fdaapprovalpulse/physio-control-inc-redmond-wa--pma-p160026-s067) - [Physio-Control, Inc.: PMA supplement approved for LIFEPAK® 35 monitor/defibrillator](/report/fdaapprovalpulse/physio-control-inc-redmond-wa--pma-p160026-s069) - [Physio-Control, Inc.: PMA supplement approved for LIFEPAK® 35 monitor/defibrillator](/report/fdaapprovalpulse/physio-control-inc-redmond-wa--pma-p160026-s071) ## Wisconsin - [Exact Sciences Corporation: PMA supplement approved for Cologuard Plus™](/report/fdaapprovalpulse/exact-sciences-corporation-madision-wi--pma-p230043-s007) - [Exact Sciences Corporation: PMA supplement approved for Cologuard Plus™](/report/fdaapprovalpulse/exact-sciences-corporation-madision-wi--pma-p230043-s006) - [Exact Sciences Corporation: PMA supplement approved for Cologuard®](/report/fdaapprovalpulse/exact-sciences-corporation-medison-wi--pma-p130017-s068) - [Merz North America, Inc.: PMA supplement approved for Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine](/report/fdaapprovalpulse/merz-north-america-inc-franksville-wi--pma-p090016-s067) - [Promega Corporation: PMA approval for OncoMate® MSI Dx Analysis System](/report/fdaapprovalpulse/promega-corporation-madison-wi--pma-p250046-orig) ## Wyoming - [Endospan , Ltd.: PMA supplement approved for NEXUS Aortic Arch Stent Graft System](/report/fdaapprovalpulse/endospan-ltd-alta-wy--pma-p250033-s004) - [Endospan , Ltd.: PMA supplement approved for NEXUS Aortic Arch Stent Graft System](/report/fdaapprovalpulse/endospan-ltd-alta-wy--pma-p250033-s002) [1](/hub/fdaapprovalpulse/records) 2 [Browse FdaApprovalPulse by category and location](/hub/fdaapprovalpulse) · [Search and filter FdaApprovalPulse](/v/fdaapprovalpulse)