FdaApprovalPulse: PMA supplement (device change), page 2 of 4
Records 51 to 200 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 |
|---|---|---|---|
| Medtronic Minimed, Inc. | MiniMed 780G System | PMA supplement (device change) | 2026-09-29 |
| Allergan | Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants | PMA supplement (device change) | 2026-09-29 |
| Bunnell, Inc. | LifePulse® High Frequency Ventilator | PMA supplement (device change) | 2026-09-28 |
| Biotronik, Inc. | Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I | PMA supplement (device change) | 2026-09-25 |
| Biotronik, Inc. | Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 | PMA supplement (device change) | 2026-09-25 |
| Beaver Visitec International, Inc. | FINEVISION HP Trifocal IOLs | PMA supplement (device change) | 2026-09-25 |
| Lungpacer Medical USA, Inc. | AeroPace® System | PMA supplement (device change) | 2026-09-25 |
| Biotronik, Inc. | Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 | PMA supplement (device change) | 2026-09-25 |
| Medtronic Cryocath, LP | STOP Persistent AF | PMA supplement (device change) | 2026-09-25 |
| Motiva USA, LLC | Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants | PMA supplement (device change) | 2026-09-25 |
| Biotronik, Inc. | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- | PMA supplement (device change) | 2026-09-25 |
| Biotronik, Inc. | Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H | PMA supplement (device change) | 2026-09-25 |
| Rayner Intraocular Lenses , Ltd. | RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X | PMA supplement (device change) | 2026-09-24 |
| Proverum, Ltd. | ProVee System for BPH | PMA supplement (device change) | 2026-09-24 |
| Impulse Dynamics (Usa), Inc. | OPTIMIZER Smart System | PMA supplement (device change) | 2026-09-24 |
| ABBOTT MEDICAL | Esprit BTK Everolimus Eluting Resorbable Scaffold System | PMA supplement (device change) | 2026-09-24 |
| ABBOTT MEDICAL | Proclaim family of SCS IPG | PMA supplement (device change) | 2026-09-23 |
| ABBOTT MEDICAL | Infinity DBS IPG | PMA supplement (device change) | 2026-09-23 |
| Medtronic | HeartWare® HVAD System | PMA supplement (device change) | 2026-09-23 |
| ABBOTT MEDICAL | Proclaim DRG IPG | PMA supplement (device change) | 2026-09-23 |
| Allurion Technologies, Inc. | Allurion Gastric Balloon System | PMA supplement (device change) | 2026-09-23 |
| Edwards Lifesciences, LLC | PASCAL Ace with Capture Clarity Valve Repair System MR Implant System | PMA supplement (device change) | 2026-09-23 |
| Boston Scientific Corp | Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Systems; Spectra Wave Writer SCS Sy | PMA supplement (device change) | 2026-09-22 |
| ABBOTT MEDICAL | TactiFlex Ablation Catheter, Sensor Enabled | PMA supplement (device change) | 2026-09-22 |
| Boston Scientific Corp | Vercise Genus DBS Systems; Vercise Gevia DBS Systems | PMA supplement (device change) | 2026-09-22 |
| Spineart USA, Inc. | BAGUERA®C Cervical Disc Prosthesis | PMA supplement (device change) | 2026-09-22 |
| Endospan , Ltd. | NEXUS Aortic Arch Stent Graft System | PMA supplement (device change) | 2026-09-21 |
| Depuy, Inc. | Attune Revision Knee System | PMA supplement (device change) | 2026-09-21 |
| Guardant Health, Inc. | Guardant360 CDx | PMA supplement (device change) | 2026-09-18 |
| Q-Med AB | Restylane® Contour | PMA supplement (device change) | 2026-09-18 |
| Ferrosan Meidcal Devices A/S | SURGIFOAM® Absorbable Gelatin Sponge | PMA supplement (device change) | 2026-09-18 |
| ABBOTT MEDICAL | Quattrode®; Octrode; Penta; Lamitrode; Tripole; TriCentrus Lead Extensions | PMA supplement (device change) | 2026-09-18 |
| Novocure, GmbH | Novocure GmbHs Optune Gio | PMA supplement (device change) | 2026-09-18 |
| Biotronik, Inc. | PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky SR-T, Amvia Edg | PMA supplement (device change) | 2026-09-17 |
| Biotronik, Inc. | PSW 2601.U, NEO 2601.U | PMA supplement (device change) | 2026-09-17 |
| Synergy Spine Solutions, Inc. | Synergy Disc | PMA supplement (device change) | 2026-09-17 |
| Biotronik, Inc. | PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, R | PMA supplement (device change) | 2026-09-17 |
| Biotronik, Inc. | Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva | PMA supplement (device change) | 2026-09-17 |
| Biotronik, Inc. | PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T | PMA supplement (device change) | 2026-09-17 |
| Xvivo Perfusion, Inc. | XPS with Steen Solution Perfusate | PMA supplement (device change) | 2026-09-16 |
| Foundation Medicine, Inc. | FoundationOne CDx | PMA supplement (device change) | 2026-09-16 |
| Insightec | Exablate Model 4000 System | PMA supplement (device change) | 2026-09-16 |
| Edwards Lifesciences, LLC | EVOQUE Tricuspid Valve Replacement System | PMA supplement (device change) | 2026-09-16 |
| Agilent Technologies, Inc. | MAGE-A4 IHC 1F9 pharmDx | PMA supplement (device change) | 2026-09-15 |
| Boston Scientific Corp | VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM | PMA supplement (device change) | 2026-09-13 |
| Pulmonx Corporation | Zephyr Endobronchial Valve System | PMA supplement (device change) | 2026-09-11 |
| Pramand, LLC | SpineSeal Spine Sealant | PMA supplement (device change) | 2026-09-11 |
| Medtronic, Inc. | Symplicity Spyral Renal Denervation System | PMA supplement (device change) | 2026-09-10 |
| Balt USA, LLC | SQUID Liquid Embolic Agent (LEA) | PMA supplement (device change) | 2026-09-09 |
| Centinel Spine, LLC | prodisc® C Nova | PMA supplement (device change) | 2026-09-09 |
| Allurion Technologies, Inc. | Allurion Gastric Balloon System | PMA supplement (device change) | 2026-09-09 |
| Zoll Manufacturing Corporation | LifeVest® Wearable Defibrillator | PMA supplement (device change) | 2026-09-09 |
| Boston Scientific Corp | WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems; Celestia and Celestia Prime SCS Systems | PMA supplement (device change) | 2026-09-09 |
| Life Technologies Corporation | Oncomine Dx Express Test | PMA supplement (device change) | 2026-09-09 |
| Vascutek, Ltd. | Thoraflex Hybrid | PMA supplement (device change) | 2026-09-08 |
| Geneoscopy, Inc. | ColoSense® | PMA supplement (device change) | 2026-09-08 |
| Seikagaku Corp. | Gel-One | PMA supplement (device change) | 2026-09-04 |
| Farapulse, Inc. | FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul | PMA supplement (device change) | 2026-09-04 |
| ABBOTT MEDICAL | TactiFlex Duo Ablation Catheter, Sensor Enabled (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDM | PMA supplement (device change) | 2026-09-04 |
| Guardant Health, Inc. | Guardant360® CDx | PMA supplement (device change) | 2026-09-04 |
| LeMaitre Vascular, Inc. | Artegraft Collagen Vascular Graft | PMA supplement (device change) | 2026-09-04 |
| Seikagaku Corp. | SUPARTZ FX | PMA supplement (device change) | 2026-09-04 |
| Rxsight, Inc. | RxSight Light Adjustable Lens and Light Delivery Device | PMA supplement (device change) | 2026-09-03 |
| Dilon Technologies, Inc. | HEMOBLAST Bellows | PMA supplement (device change) | 2026-09-03 |
| Tempus AI, Inc. | xT CDx | PMA supplement (device change) | 2026-09-02 |
| Biosense Webster, Inc. | THERMOCOOL SMARTTOUCH® SF Catheter | PMA supplement (device change) | 2026-09-02 |
| Physio-Control, Inc. | LIFEPAK® 35 monitor/defibrillator | PMA supplement (device change) | 2026-09-02 |
| Berlin Heart, Inc. | EXCOR Pediatric Ventricular Assist Device | PMA supplement (device change) | 2026-09-01 |
| Merz North America, Inc. | Belotero® Intense (+) Lidocaine | PMA supplement (device change) | 2026-08-31 |
| Pramand, LLC | SpineSeal Spine Sealant | PMA supplement (device change) | 2026-08-31 |
| Inspire Medical Systems | INSPIRE II UPPER AIRWAY STIMULATOR | PMA supplement (device change) | 2026-08-28 |
| Inspire Medical Systems | Model 4063 Inspire Stimulation Lead | PMA supplement (device change) | 2026-08-28 |
| ABBOTT MEDICAL | Amplatzer Amulet Left Atrial Appendage Occluder | PMA supplement (device change) | 2026-08-28 |
| DiaSorin, Inc. | LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus II; LIAISON C | PMA supplement (device change) | 2026-08-27 |
| Abbott Vascular, Inc. | Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Closure and Repair System | PMA supplement (device change) | 2026-08-27 |
| ETHICON, Inc. | ETHIZIA Hemostatic Patch | PMA supplement (device change) | 2026-08-27 |
| Renata Medical, Inc. | Minima Stent System; Minima Pro Stent System | PMA supplement (device change) | 2026-08-27 |
| Geneoscopy, Inc. | ColoSense® | PMA supplement (device change) | 2026-08-27 |
| DiaSorin, Inc. | LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold Plus II; LIAI | PMA supplement (device change) | 2026-08-27 |
| ABBOTT MEDICAL | Aveir VR Leadless System | PMA supplement (device change) | 2026-08-27 |
| Medtronic, Inc. | INFUSE BONE GRAFT | PMA supplement (device change) | 2026-08-26 |
| Medtronic Sofamor Danek USA, Inc. | INFUSE BONE GRAFT | PMA supplement (device change) | 2026-08-26 |
| Medtronic Sofamor Danek USA, Inc. | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | PMA supplement (device change) | 2026-08-26 |
| Siemens Healthcare Diagnostics, Inc. | Atellica IM Total PSA II (tPSAII) | PMA supplement (device change) | 2026-08-26 |
| Boston Scientific Corp | Tachy Pulse Generators | PMA supplement (device change) | 2026-08-25 |
| Defibtech, LLC | Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AED | PMA supplement (device change) | 2026-08-25 |
| Farapulse, Inc. | FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, | PMA supplement (device change) | 2026-08-25 |
| Ventana Medical Systems, Inc. | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | PMA supplement (device change) | 2026-08-25 |
| Ventana Medical Systems, Inc. | VENTANA HER2 Dual ISH DNA Probe Cocktail | PMA supplement (device change) | 2026-08-25 |
| Neuspera Medical, Inc. | Neuspera Sacral Neuromodulation (SNM) System | PMA supplement (device change) | 2026-08-21 |
| Boston Scientific Corporation | TheraSphere | PMA supplement (device change) | 2026-08-21 |
| Gyrus Acmi, Inc. | Spiration® Valve System | PMA supplement (device change) | 2026-08-20 |
| Becton, Dickinson and Company | BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 444074) | PMA supplement (device change) | 2026-08-19 |
| Nevro Corporation | HFX Dynamis System | PMA supplement (device change) | 2026-08-18 |
| DiaSorin, Inc. | LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus | PMA supplement (device change) | 2026-08-18 |
| Alcon Laboratories, LLC | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon Toric Asphe | PMA supplement (device change) | 2026-08-17 |
| Illumina, Inc. | TruSight Oncology Comprehensive | PMA supplement (device change) | 2026-08-14 |
| Spectranetics Corp. | ELCA Coronary Laser Atherectomy Catheters | PMA supplement (device change) | 2026-08-14 |
| Becton, Dickinson and Company | BD Onclarity HPV Assay | PMA supplement (device change) | 2026-08-14 |
| Recor Medical, Inc. | Paradise Ultrasound Renal Denervation System (Paradise System) | PMA supplement (device change) | 2026-08-13 |
| Bausch & Lomb, Inc. | enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) | PMA supplement (device change) | 2026-08-12 |
| Foundation Medicine, Inc. | FoundationOne Liquid CDx (F1 Liquid CDx) | PMA supplement (device change) | 2026-08-12 |
| Foundation Medicine, Inc. | FoundationOne CDx | PMA supplement (device change) | 2026-08-12 |
| LivaNova USA, Inc. | VNS Therapy System | PMA supplement (device change) | 2026-08-12 |
| Allergan | Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive | PMA supplement (device change) | 2026-08-11 |
| Allergan | Ultra, Ultra XC, Ultra Plus XC | PMA supplement (device change) | 2026-08-11 |
| Perimeter Medical Imaging Ai, Inc. | Claire OCT System | PMA supplement (device change) | 2026-08-10 |
| Irvine Biomedical,Inc.(Ibi) | Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| Baxter Healthcare Corporation | PerClot® Polysaccharide Hemostatic System | PMA supplement (device change) | 2026-08-07 |
| St Jude Medical | Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| ABBOTT MEDICAL | Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| Boston Scientific Corporation | Axonics Sacral Neuromodulation System | PMA supplement (device change) | 2026-08-07 |
| Irvine Biomedical, Inc. | Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| ABBOTT MEDICAL | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | PMA supplement (device change) | 2026-08-07 |
| Guardant Health, Inc. | Guardant360® CDx | PMA supplement (device change) | 2026-08-07 |
| Tiger Aesthetics Medical, LLC | SANAE® | PMA supplement (device change) | 2026-08-07 |
| ABBOTT MEDICAL | TactiSys Quartz Equipment; Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| St Jude Medical | TactiSys Quartz Equipment; Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| Irvine Biomedical, Inc. | Ampere Generator | PMA supplement (device change) | 2026-08-07 |
| Baxter Healthcare Corporation | PerClot® Polysaccharide Hemostatic System | PMA supplement (device change) | 2026-08-07 |
| ABBOTT MEDICAL | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | PMA supplement (device change) | 2026-08-07 |
| Boston Scientific Corporation | Axonics Sacral Neuromodulation System | PMA supplement (device change) | 2026-08-07 |
| Medtronic Cryocath, LP | Stop AF First | PMA supplement (device change) | 2026-08-06 |
| Physio-Control, Inc. | LIFEPAK® 35 monitor/defibrillator | PMA supplement (device change) | 2026-08-06 |
| Farapulse, Inc. | FARAPULSE Pulsed Field Ablation System | PMA supplement (device change) | 2026-08-06 |
| Depuy, Inc. | ATTUNE Revision Knee System | PMA supplement (device change) | 2026-08-05 |
| Medtronic | HeartWare HVAD System | PMA supplement (device change) | 2026-08-05 |
| Pramand, LLC | CraniSeal Dural Sealant | PMA supplement (device change) | 2026-08-05 |
| Ev3 Neurovascular | Onyx Liquid Embolic System (LES) | PMA supplement (device change) | 2026-08-05 |
| Boston Scientific Corporation | Ranger Paclitaxel-Coated Balloon Catheter | PMA supplement (device change) | 2026-08-04 |
| Alcon Laboratories | VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System. | PMA supplement (device change) | 2026-08-04 |
| Alcon Research, Ltd. | PROVISC Ophthalmic Viscosurgical Device | PMA supplement (device change) | 2026-08-04 |
| Terumo Medical Corporation | Angio Seal VIP Vascular Closure Device | PMA supplement (device change) | 2026-08-04 |
| W. L. Gore & Associates, Inc. | GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder | PMA supplement (device change) | 2026-08-03 |
| Lynch Biologics, LLC | GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid | PMA supplement (device change) | 2026-08-03 |
| Stereotaxis, Inc. | MAGiC Ablation Catheter | PMA supplement (device change) | 2026-07-31 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Scoreflex NC Scoring PTCA Catheter | PMA supplement (device change) | 2026-07-31 |
| Dt Medtech, LLC | Hintermann Series H3 Total Ankle Replacement System | PMA supplement (device change) | 2026-07-31 |
| Medtronic | HeartWare® Ventricular Assist System | PMA supplement (device change) | 2026-07-28 |
| Medtronic Sofamor Danek USA, Inc. | Infuse TM Bone Graft/Medtronic lnterbody Fusion Device | PMA supplement (device change) | 2026-07-28 |
| Medtronic Sofamor Danek USA, Inc. | Infuse Bone Graft | PMA supplement (device change) | 2026-07-28 |
| Cleveland Diagnostics, Inc. | IsoPSA® Assay | PMA supplement (device change) | 2026-07-28 |
| Medtronic, Inc. | Infuse Bone Graft | PMA supplement (device change) | 2026-07-28 |
| ETHICON, Inc. | SURGICELTM POWDER Absorbable Hemostatic Powder | PMA supplement (device change) | 2026-07-28 |
| Biomet Microfixation, Inc. | Total Temporomandibular Joint Replacement System | PMA supplement (device change) | 2026-07-27 |
| Boston Scientific Corporation | Axonics Sacral Neuromodulation System | PMA supplement (device change) | 2026-07-24 |
| Endospan , Ltd. | NEXUS Aortic Arch Stent Graft System | PMA supplement (device change) | 2026-07-24 |
| Boston Scientific Corporation | Axonics Sacral Neuromodulation System | PMA supplement (device change) | 2026-07-24 |
| Defibtech, LLC | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- | PMA supplement (device change) | 2026-07-24 |
| ABBOTT MEDICAL | TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C | PMA supplement (device change) | 2026-07-23 |
All FdaApprovalPulse record reports