PMA records

PMA, Device, Applicant table
PMADeviceApplicantDecision date
P980023S151Acticor 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, RivaBiotronik, Inc.2026-09-25
P980023S140Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569Biotronik, Inc.2026-09-25
P980016S965Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICDMedtronic Cardiac Rhythm Disease Management2026-09-25
P950037S279Edora 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-Biotronik, Inc.2026-09-25
P830055S375LCS® Total Knee SystemDepuy, Inc.2026-09-25
P250050Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc.2026-09-25
P240038S003FINEVISION HP Trifocal IOLsBeaver Visitec International, Inc.2026-09-25
P240012S008AeroPace® SystemLungpacer Medical USA, Inc.2026-09-25
P230040S033Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.2026-09-25
P230005S005Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast ImplantsMotiva USA, LLC2026-09-25
P100010S154STOP Persistent AFMedtronic Cryocath, LP2026-09-25
P070008S172Edora 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 HBiotronik, Inc.2026-09-25
P050023S214Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, Rivacor Sky HF-T QP, RivaBiotronik, Inc.2026-09-25
P050023S204Ilivia 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; IBiotronik, Inc.2026-09-25
P010031S932Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-DMedtronic Cardiac Rhythm Disease Management2026-09-25
P000009S133Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-TBiotronik, Inc.2026-09-25
P000009S124Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568Biotronik, Inc.2026-09-25
P960043S137Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair SystemAbbott Vascular, Inc.2026-09-24
P960009S546MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.2026-09-24
P840001S634Vanta™with AdaptiveStim™ Technology - Model 977006Medtronic Neuromodulation2026-09-24
P250011S006ProVee System for BPHProverum, Ltd.2026-09-24
P230036S020Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemABBOTT MEDICAL2026-09-24
P200002S015EPi- Sense ST Coagulation SystemAtriCure, Inc.2026-09-24
P180047S046LIAISON® QuantiFERON®-TB Gold Plus II.DiaSorin, Inc.2026-09-24
P180036S044OPTIMIZER Smart SystemImpulse Dynamics (Usa), Inc.2026-09-24
P170030S066ORSIRO Sirolimus Eluting Coronary Stent SystemBiotronik AG2026-09-24
P160026S074LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DEPhysio-Control, Inc.2026-09-24
P140010S106IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterMedtronic, Inc.2026-09-24
P100046S021Synergy Ablation SystemAtriCure, Inc.2026-09-24
P060037S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc.2026-09-24
P060011S045RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615XRayner Intraocular Lenses , Ltd.2026-09-24
P250023S002Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.2026-09-23
P220003S028PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant SystemEdwards Lifesciences, LLC2026-09-23
P200015S083Edwards Crimper (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29)Edwards Lifesciences, LLC2026-09-23
P150004S100Proclaim DRG IPGABBOTT MEDICAL2026-09-23
P140031S209Edwards Crimper (9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26, 9750CM29)Edwards Lifesciences, LLC2026-09-23
P140009S139Infinity DBS IPGABBOTT MEDICAL2026-09-23
P100047S241HeartWare® HVAD SystemMedtronic2026-09-23
P100044S060Propel Family ProductsIntersect Ent.2026-09-23
P010032S260Proclaim family of SCS IPGABBOTT MEDICAL2026-09-23