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Registry

363 FDA decisions, each verified against the agency record

20 510(k) clearances and 343 PMA decisions for electrophysiology devices, newest first. The identifier links to the FDA record.

DateApplicantDeviceIdentifierKind
2026-02-11Medtronic, Inc.Aurora EV ICDP220012/S065PMA supplement
2026-02-11Biotronik, Inc.DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSP950037/S283PMA supplement
2026-02-11Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; Mirro truncated in FDA recordP980016/S947PMA supplement
2026-02-11Biotronik, Inc.PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMP980023/S142PMA supplement
2026-02-10Medtronic, Inc.Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T truncated in FDA recordP010015/S578PMA supplement
2026-02-10Medtronic, Inc.Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua truncated in FDA recordP010015/S579PMA supplement
2026-02-10Medtronic Cardiac Rhythm Disease ManagementAmplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt truncated in FDA recordP010031/S915PMA supplement
2026-02-10Medtronic Cardiac Rhythm Disease ManagementSelectSecure LeadP030036/S156PMA supplement
2026-02-10Medtronic, Inc.Attain StarFix LeadP060039/S119PMA supplement
2026-02-10Medtronic, Inc.Micra AV2 TPS; Micra VR2 TPSP150033/S220PMA supplement
2026-02-10Medtronic, Inc.Aurora EV ICD DVEA3E4P220012/S066PMA supplement
2026-02-10Medtronic Cardiac Rhythm Disease ManagementCapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen truncated in FDA recordP830061/S233PMA supplement
2026-02-10Medtronic Cardiac Rhythm Disease ManagementCapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JBP850089/S173PMA supplement
2026-02-10Medtronic, Inc.HV Splitter/Adaptor kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 truncated in FDA recordP920015/S302PMA supplement
2026-02-10Medtronic, Inc.CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall truncated in FDA recordP930039/S275PMA supplement
2026-02-10Medtronic, Inc.CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968)P950024/S116PMA supplement
2026-02-10Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I truncated in FDA recordP980016/S948PMA supplement
2026-02-03Biotronik, Inc.PHYLAX AV ICD SYSTEMP000009/S126PMA supplement
2026-02-03Biotronik, Inc.TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADP050023/S206PMA supplement
2026-02-03Biotronik, Inc.STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADP070008/S174PMA supplement
2026-02-03ABBOTT MEDICALTactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T truncated in FDA recordP220013/S027PMA supplement
2026-02-03Biotronik, Inc.DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSP950037/S284PMA supplement
2026-02-03Biotronik, Inc.PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMP980023/S143PMA supplement
2026-01-29Zoll Manufacturing CorporationLifeVest® Wearable DefibrillatorP010030/S199PMA supplement
2026-01-23Boston Scientific Cardiac Diagnostic Technologies, Inc.BodyGuardian Remote Monitoring System (BGRMS v3.0)K243349510(k)
2026-01-23Medtronic, Inc.Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar truncated in FDA recordP010015/S576PMA supplement
2026-01-23Medtronic, Inc.Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P truncated in FDA recordP010015/S577PMA supplement
2026-01-23Medtronic Cardiac Rhythm Disease ManagementAmplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt truncated in FDA recordP010031/S912PMA supplement
2026-01-23Medtronic, Inc.Aurora EV-ICD SystemP220012/S064PMA supplement
2026-01-23Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve truncated in FDA recordP980016/S945PMA supplement
2026-01-16Medtronic Cardiac Rhythm Disease ManagementCobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-DP010031/S913PMA supplement
2026-01-16Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICDP980016/S946PMA supplement
2026-01-15Irvine Biomedical,Inc.(Ibi)Safire™ TX Bi-directional and Therapy™ Dual-8™P040042/S058PMA supplement
2026-01-15ABBOTT MEDICALFlexAbility™ and FlexAbility™ Sensor Enabled™P110016/S092PMA supplement
2026-01-15MicroPort CRM USA, Inc.VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)P130010/S005PMA supplement
2026-01-15St Jude MedicalTactiCath™ Sensor Enabled™P130026/S098PMA supplement
2026-01-15ABBOTT MEDICALTactiFlex™ Sensor Enabled™P220013/S026PMA supplement
2026-01-15St Jude MedicalLivewire™ TC XLS™P960016/S093PMA supplement
2026-01-13Element Science, Inc.Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati truncated in FDA recordP230022/S006PMA supplement
2026-01-13Farapulse, Inc.FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)P230030/S017PMA supplement
2026-01-12Farapulse, Inc.FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C truncated in FDA recordP230030/S012PMA supplement
2026-01-09Boston ScientificINGEVITY™ Family Bradycardia LeadsP150012/S177PMA supplement
2026-01-09Kardium, Inc.Globe® Catheter; Globe® Pulsed Field SystemP240044/S004PMA supplement
2026-01-08Imricor Medical Systems, Inc.Vision-MR™ Diagnostic CatheterK252794510(k)
2026-01-08Boston Scientific CorpAccolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, truncated in FDA recordN970003/S301PMA supplement
2026-01-08Boston Scientific CorpNG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode truncated in FDA recordP010012/S592PMA supplement
2026-01-08Guidant Corp.Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 truncated in FDA recordP030005/S247PMA supplement
2026-01-08Medtronic Cardiac Rhythm Disease ManagementSelectSecure Lead 3830P030036/S155PMA supplement
2026-01-08ABBOTT MEDICALFlexAbility™ Ablation Catheter (Flex) and FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE)P110016/S091PMA supplement
2026-01-08Boston Scientific CorporationSubcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219P110042/S204PMA supplement

Source: openFDA device/510k and device/pma, verified rows only, as the FDA names each applicant and device; last verified 20 September 2026.