PMA records

PMA, Device, Applicant table
PMADeviceApplicantDecision date
P970004S452InterStim TM Therapy System; Verify TM Evaluation System (97800)Medtronic Neuromodulation2026-06-05
P960009S536Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (B35200)Medtronic, Inc.2026-06-05
P840001S628Master Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™; Specify™Medtronic Neuromodulation2026-06-05
P230038AbsorbaSeal 5.6.7F Vascular Closure DeviceCyndrx, LLC2026-06-05
P230030S021FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,Farapulse, Inc.2026-06-05
P220013S031TactiFlex™ Ablation Catheter, Sensor Enabled™ABBOTT MEDICAL2026-06-05
P210037S017Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLockBiotronik Nro, Inc.2026-06-05
P200035S039OrganOx metra® SystemOrganox Limited2026-06-05
P200032S006Occlutech® ASD Occluder and Occlutech® Pistol PusherOcclutech Holding AG2026-06-05
P170030S052Orsiro Mission Sirolimus Eluting Coronary Stent SystemBiotronik AG2026-06-05
P160043S094Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent SMedtronic Vascular2026-06-05
P160022S051CPR Uni-padz ElectrodeZOLL Medical Corporation2026-06-05
P160003S024PRO-Kinetic Energy Coronary Stent SystemBiotronik AG2026-06-05
P130026S100TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™St Jude Medical2026-06-05
P110016S094FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTMABBOTT MEDICAL2026-06-05
P080025S347InterStim TM Therapy System; Verify TM Evaluation System (97800)Medtronic Neuromodulation2026-06-05
P030047S055PRECISE PRO RX Nitinol Stent SystemCordis US Corporation2026-06-05
P970004S451InterStim™ Therapy System; Verify™ Evaluation System; InterStim SNS Urinary Lead Model 978B1Medtronic Neuromodulation2026-06-04
P850010S118Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent - Fibrillar FormIntegra LifeSciences Corporation2026-06-04
P840062S098CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental SurgeryIntegra Lifesciences Corp.2026-06-04
P810006S114Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar FoIntegra LifeSciences Corporation2026-06-04
P210034S001Agili-CSmith and Nephew, Inc.2026-06-04
P200029S013TheraSphere™ Y-90 Glass Microspheres SystemBoston Scientific Corporation2026-06-04
P200015S076Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive PrestentEdwards Lifesciences, LLC2026-06-04
P170034S018Hydrus® MicrostentAlcon Research, LLC2026-06-04
P150033S224Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPSMedtronic, Inc.2026-06-04
P100034S042Optune GioNovocure, GmbH2026-06-04
P090015S014BOND Oracle HER2 IHC SystemLeica Biosystems2026-06-04
P080025S346InterStim TM Therapy System; Verify™ Evaluation System; InterStim SNS Bowel Lead Model 978B1Medtronic Neuromodulation2026-06-04
P990080S066TECNIS™ 3-Piece Acrylic Monofocal, Model ZA9003Johnson & Johnson Surgical Vision, Inc.2026-06-03
P980040S183SENSAR™ 3-Piece Monofocal IOL, Models, AR40e, AR40E, AR40M, AR40MNJohnson & Johnson Surgical Vision, Inc.2026-06-03
P960040S514INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HFBoston Scientific2026-06-03
P960004S116ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480Boston Scientific2026-06-03
P910073S191Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266Boston Scientific2026-06-03
P860057S226Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic BioprosthesisEdwards Lifesciences, LLC2026-06-03
P830055S366LCS® Total Knee SystemDepuy, Inc.2026-06-03
P250011S002ProVee System for BPHProverum, Ltd.2026-06-03
P190023S029Navitor™ TAVI System with Vision TechnologyABBOTT MEDICAL2026-06-03
P150048S101INSPIRIS RESILIA Aortic ValveEdwards Lifesciences, LLC2026-06-03
P150012S186Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832Boston Scientific2026-06-03