FdaApprovalPulse: PMA supplement (device change), page 3 of 4
Records 201 to 350 of the 367 newest listed for this hub. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
| Record | Product | Approval | Decided |
|---|---|---|---|
| ABBOTT MEDICAL | Current PFA Generator TactiFlex Duo | PMA supplement (device change) | 2026-07-23 |
| Abbott Molecular, Inc. | Alinity m HR HPV | PMA supplement (device change) | 2026-07-23 |
| Guardant Health, Inc. | Shield | PMA supplement (device change) | 2026-07-22 |
| Mentor Corp. | MENTOR MemoryGel Breast Implants | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Assurity, Assurity+, Endurity, Accent family of Pacemakers | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Microny family of Pacemakers | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Aveir Leadless System | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ | PMA supplement (device change) | 2026-07-21 |
| Mentor Worldwide, LLC | MENTOR MemoryShape Breast Implants | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps | PMA supplement (device change) | 2026-07-21 |
| ABBOTT MEDICAL | Assurity MRI / Endurity MRI Pacemakers | PMA supplement (device change) | 2026-07-21 |
| Boston Scientific Corp | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure | PMA supplement (device change) | 2026-07-21 |
| Edwards Lifesciences, LLC | Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 | PMA supplement (device change) | 2026-07-17 |
| Edwards Lifesciences, LLC | Edwards Crimper: 9600CR | PMA supplement (device change) | 2026-07-17 |
| ZOLL Medical Corporation | AED 3; CPR Uni-Padz | PMA supplement (device change) | 2026-07-16 |
| Terumo Medical Corporation | MISAGO(TM) RX Self-expanding Peripheral Stent | PMA supplement (device change) | 2026-07-16 |
| Medtronic, Inc. | Symplicity Spyral Renal Denervation System | PMA supplement (device change) | 2026-07-16 |
| Stryker Leibinger GmbH & Co KG | Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant | PMA supplement (device change) | 2026-07-15 |
| Cryolife, Inc. | BioGlue® Surgical Adhesive | PMA supplement (device change) | 2026-07-15 |
| Medtronic, Inc. | Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX Transcatheter Aortic Valve Repl | PMA supplement (device change) | 2026-07-14 |
| Acu Focus, Inc. | IC-8 Apthera Intraocular Lens (IOL) | PMA supplement (device change) | 2026-07-14 |
| Microcube, LLC | Minitouch 3.8 Era System (Minitouch System) | PMA supplement (device change) | 2026-07-13 |
| W. L. Gore & Associates, Inc. | GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 | PMA supplement (device change) | 2026-07-13 |
| Inspire Medical Systems | Model 3150 Implantable Pulse Generator (IPG) | PMA supplement (device change) | 2026-07-10 |
| Medtronic, Inc. | HexaGen RF Generator Software and Remote | PMA supplement (device change) | 2026-07-10 |
| ABBOTT MEDICAL | Volt PFA System | PMA supplement (device change) | 2026-07-10 |
| ABBOTT MEDICAL | Navitor Transcatheter Aortic Valve Implantation System | PMA supplement (device change) | 2026-07-09 |
| Lutonix | Lutonix 018 Drug Coated Balloon PTA Catheter | PMA supplement (device change) | 2026-07-09 |
| ABBOTT MEDICAL | Esprit BTK Everolimus Eluting Resorbable Scaffold System | PMA supplement (device change) | 2026-07-09 |
| Renata Medical, Inc. | Minima Pro Stent System | PMA supplement (device change) | 2026-07-09 |
| Lutonix | Lutonix 035 Drug Coated Balloon Catheter | PMA supplement (device change) | 2026-07-09 |
| W. L. Gore and Associates, Inc. | GORE® EXCLUDER® Conformable AAA Endoprosthesis | PMA supplement (device change) | 2026-07-08 |
| Channel Medsystems, Inc. | Cerene® Cryotherapy Device | PMA supplement (device change) | 2026-07-08 |
| W. L. Gore & Associates, Inc. | GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis | PMA supplement (device change) | 2026-07-08 |
| Organox Limited | OrganOx metra® System | PMA supplement (device change) | 2026-07-07 |
| Boston Scientific Corporation | EMBLEM S-ICD Electrode (Lead) Model 3501 | PMA supplement (device change) | 2026-07-07 |
| NuMED, Inc. | CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42 | PMA supplement (device change) | 2026-07-06 |
| W. L. Gore & Associates, Inc. | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | PMA supplement (device change) | 2026-07-01 |
| Boston Scientific Corporation | EMBLEM S-ICD | PMA supplement (device change) | 2026-07-01 |
| Siemens Medical Solutions USA, Inc. | MAMMOMAT B.brilliant with Tomosynthesis Option | PMA supplement (device change) | 2026-07-01 |
| Novocure, GmbH | Optune Lua® | PMA supplement (device change) | 2026-07-01 |
| Guidant Corp. | INVIVE, INTUA, VISIONIST, VALITUDE | PMA supplement (device change) | 2026-07-01 |
| Carl Zeiss Meditec, Inc. | MEL 90 Excimer Laser | PMA supplement (device change) | 2026-07-01 |
| Agilent Technologies, Inc. | PD-L1 IHC 28-8 pharmDx | PMA supplement (device change) | 2026-07-01 |
| Boston Scientific Corp | COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT | PMA supplement (device change) | 2026-07-01 |
| Biosense Webster, Inc. | Dual Energy THERMOCOOL SMARTTOUCH SF System | PMA supplement (device change) | 2026-07-01 |
| Novocure, GmbH | Optune Pax® | PMA supplement (device change) | 2026-07-01 |
| Boston Scientific Corp | ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 | PMA supplement (device change) | 2026-07-01 |
| Biosense Webster, Inc. | VISITAG SURPOINT External Processing Unit (EPU); CARTO 3 System | PMA supplement (device change) | 2026-06-30 |
| ABBOTT MEDICAL | Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) | PMA supplement (device change) | 2026-06-30 |
| Biosense Webster, Inc. | VARIPULSE Catheter, TRUPULSE Generator with Connection Interface Unit (CIU) | PMA supplement (device change) | 2026-06-30 |
| Saluda Medical Pty, Ltd. | CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer | PMA supplement (device change) | 2026-06-29 |
| Depuy, Inc. | LCS® Total Knee System | PMA supplement (device change) | 2026-06-29 |
| Saluda Medical Pty, Ltd. | Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042) | PMA supplement (device change) | 2026-06-29 |
| Rxsight, Inc. | RxSight Light Adjustable Lens; Light Delivery Device | PMA supplement (device change) | 2026-06-26 |
| Illumina, Inc. | TruSight Oncology Comprehensive | PMA supplement (device change) | 2026-06-26 |
| Medtronic, Inc. | Aurora EV ICD DVEA3E4 | PMA supplement (device change) | 2026-06-25 |
| Defibtech, LLC | Defibtech Automated External Defibrillator (AED) Systems | PMA supplement (device change) | 2026-06-25 |
| ETHICON, Inc. | ETHIZIA Hemostatic Patch | PMA supplement (device change) | 2026-06-25 |
| Medtronic Cardiac Rhythm Disease Management | Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M | PMA supplement (device change) | 2026-06-25 |
| Medtronic Cardiac Rhythm Disease Management | Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1, DTBC1QQ Cl | PMA supplement (device change) | 2026-06-25 |
| Shockwave Medical, Inc. | Shockwave lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL Catheter | PMA supplement (device change) | 2026-06-24 |
| Kardium, Inc. | Globe® Catheter and Globe® Pulsed Field System | PMA supplement (device change) | 2026-06-23 |
| Cordis US Corporation | Exoseal Vascular Closure Device | PMA supplement (device change) | 2026-06-23 |
| Lungpacer Medical USA, Inc. | AeroPace® System | PMA supplement (device change) | 2026-06-22 |
| Lungpacer Medical USA, Inc. | AeroPace® System | PMA supplement (device change) | 2026-06-22 |
| ABBOTT MEDICAL | Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves | PMA supplement (device change) | 2026-06-22 |
| LivaNova USA, Inc. | aura6000 system | PMA supplement (device change) | 2026-06-18 |
| NeuroPace, Inc. | NeuroPace® RNS® System | PMA supplement (device change) | 2026-06-17 |
| Roche Molecular Systems, Inc. | cobas HPV | PMA supplement (device change) | 2026-06-16 |
| Defibtech, LLC | Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E | PMA supplement (device change) | 2026-06-16 |
| Abiomed, Inc. | Impella CP with SmartAssist | PMA supplement (device change) | 2026-06-15 |
| Medtronic Minimed, Inc. | MiniMed 780G System | PMA supplement (device change) | 2026-06-12 |
| Medtronic Minimed, Inc. | Simplera Sync Sensor | PMA supplement (device change) | 2026-06-12 |
| ABBOTT MEDICAL | The AVEIR Leadless Pacemaker (LP) | PMA supplement (device change) | 2026-06-11 |
| ABBOTT MEDICAL | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten | PMA supplement (device change) | 2026-06-11 |
| Allergan | SKINVIVE by JUVEDERM® | PMA supplement (device change) | 2026-06-11 |
| ABBOTT MEDICAL | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten | PMA supplement (device change) | 2026-06-11 |
| Medibeacon, Inc. | MediBeacon® Transdermal GFR Measurement System (TGFR) | PMA supplement (device change) | 2026-06-10 |
| ABBOTT MEDICAL | HeartMate II Left Ventricular Assist System (LVAS) | PMA supplement (device change) | 2026-06-10 |
| Guardant Health, Inc. | Guardant360 CDx | PMA supplement (device change) | 2026-06-10 |
| ABBOTT MEDICAL | HeartMate 3 Left Ventricular Assist System (LVAS) | PMA supplement (device change) | 2026-06-10 |
| Medtronic, Inc. | Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th | PMA supplement (device change) | 2026-06-09 |
| Rxsight, Inc. | RxSight Light Adjustable Lens; Light Delivery Device | PMA supplement (device change) | 2026-06-08 |
| Abbott Molecular, Inc. | Alinity m HR HPV Assay | PMA supplement (device change) | 2026-06-08 |
| Baxter Healthcare Corporation | PerClot® Polysaccharide Hemostatic System | PMA supplement (device change) | 2026-06-08 |
| Cordis US Corporation | PRECISE PRO RX Nitinol Stent System | PMA supplement (device change) | 2026-06-05 |
| ZOLL Medical Corporation | CPR Uni-padz Electrode | PMA supplement (device change) | 2026-06-05 |
| Edwards Lifesciences, LLC | Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent | PMA supplement (device change) | 2026-06-04 |
| Medtronic, Inc. | Micra Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS | PMA supplement (device change) | 2026-06-04 |
| Smith and Nephew, Inc. | Agili-C | PMA supplement (device change) | 2026-06-04 |
| Novocure, GmbH | Optune Gio | PMA supplement (device change) | 2026-06-04 |
| ABBOTT MEDICAL | Navitor TAVI System with Vision Technology | PMA supplement (device change) | 2026-06-03 |
| Endologix, LLC | Alto Abdominal Stent Graft System | PMA supplement (device change) | 2026-06-03 |
| Exact Sciences Corporation | Cologuard Plus | PMA supplement (device change) | 2026-06-02 |
| Coloplast Corp. | Titan Inflatable Penile Prosthesis (IPP) | PMA supplement (device change) | 2026-06-02 |
| ABBOTT MEDICAL | CardioMEMS HF System | PMA supplement (device change) | 2026-06-01 |
| ABBOTT MEDICAL | Aveir VR (LSCD111); DR Delivery Catheter (LSCD201) | PMA supplement (device change) | 2026-05-29 |
| Premia Spine, Ltd. | TOPS System | PMA supplement (device change) | 2026-05-29 |
| Boston Scientific Corporation | POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console | PMA supplement (device change) | 2026-05-29 |
| ABBOTT MEDICAL | HeartMate II Left Ventricular Assist System | PMA supplement (device change) | 2026-05-29 |
| ABBOTT MEDICAL | HeartMate 3 Left Ventricular Assist System | PMA supplement (device change) | 2026-05-29 |
| Tempus AI, Inc. | xT CDx | PMA supplement (device change) | 2026-05-28 |
| Boston Scientific Corp | Deep Brain Stimulation (DBS) Systems | PMA supplement (device change) | 2026-05-28 |
| Medtronic Cardiac Rhythm Disease Management | SelectSecure Lead Model 3830 | PMA supplement (device change) | 2026-05-28 |
| Boston Scientific Corp | Spinal Cord Stimulation (SCS) | PMA supplement (device change) | 2026-05-28 |
| Medtronic, Inc. | Affera Ablation System | PMA supplement (device change) | 2026-05-28 |
| NeuroPace, Inc. | NeuroPace® RNS® System | PMA supplement (device change) | 2026-05-28 |
| ABBOTT MEDICAL | TactiFlex Sensor Enabled Ablation Catheter | PMA supplement (device change) | 2026-05-28 |
| Foundation Medicine, Inc. | FoundationOne CDx (F1CDx) | PMA supplement (device change) | 2026-05-27 |
| Exact Sciences Corporation | Cologuard® | PMA supplement (device change) | 2026-05-27 |
| Foundation Medicine, Inc. | FoundationOne CDx (F1CDx) | PMA supplement (device change) | 2026-05-27 |
| Exact Sciences Corporation | Cologuard Plus | PMA supplement (device change) | 2026-05-27 |
| Biomet Manufacturing Corp | Oxford Partial Knee System; Cementless OxfordPartial Knee System | PMA supplement (device change) | 2026-05-27 |
| Foundation Medicine, Inc. | FoundationOne Liquid CDx | PMA supplement (device change) | 2026-05-27 |
| Foundation Medicine, Inc. | FoundationOne CDx | PMA supplement (device change) | 2026-05-27 |
| Foundation Medicine, Inc. | FoundationOne CDx (F1CDx) | PMA supplement (device change) | 2026-05-27 |
| ABBOTT MEDICAL | HeartMate 3 Left Ventricular Assist System | PMA supplement (device change) | 2026-05-27 |
| Carl Zeiss Meditec, Inc. | VISUMAX 800 Femtosecond Laser | PMA supplement (device change) | 2026-05-26 |
| Edwards Lifesciences, LLC | TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm | PMA supplement (device change) | 2026-05-26 |
| Envoy Medical Corporation | Esteem® | PMA supplement (device change) | 2026-05-21 |
| Organox Limited | OrganOx metra® System | PMA supplement (device change) | 2026-05-21 |
| Philips Medical Systems, Inc. | HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator | PMA supplement (device change) | 2026-05-21 |
| Boston Scientific Corp | Celestia Implantable Pulse Generator, Celestia External Trial Stimulator | PMA supplement (device change) | 2026-05-21 |
| Philips Medical Systems | HeartStart FRx Defibrillator (861304) | PMA supplement (device change) | 2026-05-21 |
| AutoGenomics, Inc. | AvertD and AvertD Buccal Sample Collection Kit | PMA supplement (device change) | 2026-05-20 |
| Medtronic, Inc. | Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense | PMA supplement (device change) | 2026-05-20 |
| Johnson & Johnson Surgical Vision, Inc. | TECNIS Eyhance Toric II IOLs with SmartLOAD Delivery Technology (GIU150-600) | PMA supplement (device change) | 2026-05-19 |
| JenaValve Technology, Inc. | Trilogy Transcatheter Heart Valve System | PMA supplement (device change) | 2026-05-18 |
| Boston Scientific Corp | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure | PMA supplement (device change) | 2026-05-18 |
| Boston Scientific Corp | AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone | PMA supplement (device change) | 2026-05-18 |
| JenaValve Technology, Inc. | Trilogy Transcatheter Heart Valve System | PMA supplement (device change) | 2026-05-18 |
| Ventana Medical Systems, Inc. | HER2 Dual ISH DNA Probe Cocktail | PMA supplement (device change) | 2026-05-15 |
| Abbott Molecular, Inc. | Alinity m HR HPV | PMA supplement (device change) | 2026-05-15 |
| Medtronic, Inc. | Sphere-9 Catheter and Affera Ablation System | PMA supplement (device change) | 2026-05-15 |
| Bard Peripheral Vascular, Inc. | LifeStent 5F Vascular Stent System | PMA supplement (device change) | 2026-05-15 |
| Alcon Laboratories, LLC | Clareon Vivity Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL) | PMA supplement (device change) | 2026-05-15 |
| Q-Med AB | Restylane® Contour | PMA supplement (device change) | 2026-05-15 |
| Ventana Medical Systems, Inc. | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | PMA supplement (device change) | 2026-05-15 |
| W. L. Gore and Associates, Inc. | GORE® EXCLUDER® Conformable AAA Endoprosthesis | PMA supplement (device change) | 2026-05-14 |
| W. L. Gore & Associates, Inc. | GORE® EXCLUDER® AAA Endoprosthesis | PMA supplement (device change) | 2026-05-14 |
| Medtronic, Inc. | Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur | PMA supplement (device change) | 2026-05-14 |
| Cordis US Corporation | Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure | PMA supplement (device change) | 2026-05-14 |
| Medtronic, Inc. | Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar | PMA supplement (device change) | 2026-05-14 |
| Biotronik Nro, Inc. | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | PMA supplement (device change) | 2026-05-14 |
| Theragen, Inc. | ActaStim-S | PMA supplement (device change) | 2026-05-13 |
| Atrium Medical Corp. | iCast Covered Stent System | PMA supplement (device change) | 2026-05-13 |
| TransMedics, Inc. | Organ Care System (OCS) Liver | PMA supplement (device change) | 2026-05-13 |
| TransMedics, Inc. | Organ Care System (OCS) Lung System | PMA supplement (device change) | 2026-05-13 |
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