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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
2026-03-18Boston ScientificINGEVITY™+ Pace / Sense Lead – Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J truncated in FDA recordP150012/S178PMA supplement
2026-03-13Cortex, Inc.OptiMap Catheter - 50mm (OPTI-CATH2-50)K253205510(k)
2026-03-09Medtronic, Inc.OmniaSecure™ MRI SureScan™ Lead Model 3930MP240036/S004PMA supplement
2026-03-06Medtronic, Inc.Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P truncated in FDA recordP010015/S582PMA supplement
2026-03-06Medtronic 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/S920PMA supplement
2026-03-06Medtronic Cardiac Rhythm Disease ManagementSelectSecure LeadP030036/S157PMA supplement
2026-03-06Kestra Medical Technologies, Inc.ASSURE Wearable Cardioverter Defibrillator (WCD) SystemP200037/S018PMA supplement
2026-03-06Medtronic, Inc.Aurora EV ICD; Epsila EV Extravascular LeadP220012/S068PMA supplement
2026-03-06Medtronic, Inc.Sphere-9 Catheter (AFR-00001)P240013/S020PMA supplement
2026-03-06Boston ScientificENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leadsP910073/S187PMA supplement
2026-03-06Medtronic, Inc.HV Splitter/ Adaptor kitP920015/S304PMA supplement
2026-03-06Medtronic 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 I CD; Ev truncated in FDA recordP980016/S953PMA supplement
2026-03-05Biotronik, Inc.Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 truncated in FDA recordP050023/S208PMA supplement
2026-03-05Biotronik, 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 (4071 truncated in FDA recordP070008/S176PMA supplement
2026-03-05Biotronik, 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); En truncated in FDA recordP950037/S286PMA supplement
2026-03-05Biotronik, Inc.Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk truncated in FDA recordP980023/S144PMA supplement
2026-03-04Medtronic Cardiac Rhythm Disease ManagementCobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M truncated in FDA recordP010031/S919PMA supplement
2026-03-04Element Science, Inc.Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class truncated in FDA recordP230022/S003PMA supplement
2026-03-04Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I truncated in FDA recordP980016/S952PMA supplement
2026-03-03Medtronic, Inc.HexaGen™ RF GeneratorP240013/S019PMA supplement
2026-02-23Medtronic, Inc.Miera AV TPS; Miera TPSP150033/S222PMA supplement
2026-02-23ABBOTT MEDICALAveir DR Delivery Catheter (LSCD201)P150035/S034PMA supplement
2026-02-20Boston Scientific CorporationEMBLEM S-ICD Electrode (Lead)P110042/S203PMA supplement
2026-02-20Medtronic, Inc.Myocardial Pacing LeadP120017/S039PMA supplement
2026-02-20Boston ScientificENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leadsP910073/S185PMA supplement
2026-02-19ABBOTT MEDICALQuartet; QuickFlex MicroP030054/S435PMA supplement
2026-02-19ABBOTT MEDICALAveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular)P150035/S026PMA supplement
2026-02-19ABBOTT MEDICALDurata, OptisureP950022/S148PMA supplement
2026-02-19ABBOTT MEDICALTendril STS; OptiSense; UltiPaceP960013/S129PMA supplement
2026-02-19ABBOTT MEDICALIsoFlexP960030/S080PMA supplement
2026-02-18Kardium, Inc.Globe Catheter (601-01000)P240044/S002PMA supplement
2026-02-17Medtronic, Inc.PulseSelect™ Pulsed Field Ablation (PFA) systemP230017/S009PMA supplement
2026-02-13Measure Labs, Inc. (Dba Preemptiveai, Inc.)PreemptiveAI Clinical SDKK250233510(k)
2026-02-13Boston Scientific CorpACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod truncated in FDA recordP010012/S602PMA supplement
2026-02-13ABBOTT MEDICALAvant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); truncated in FDA recordP030054/S441PMA supplement
2026-02-13Boston Scientific CorporationEMBLEM™ S-ICD/ model 3501P110042/S208PMA supplement
2026-02-13Boston ScientificINGEVITY™ MRI/ model 7731; INGEVITY™ MRI/ model 7732; INGEVITY™ MRI/ model 7735; INGEVITY™ MRI/ model 7736; INGEVITY™ MR truncated in FDA recordP150012/S179PMA supplement
2026-02-13ABBOTT MEDICALAvant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); truncated in FDA recordP910023/S483PMA supplement
2026-02-13Boston ScientificRELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC truncated in FDA recordP910073/S186PMA supplement
2026-02-13Medtronic, Inc.Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M)P920015/S303PMA supplement
2026-02-12Medtronic, Inc.Consulta CRT-P C4TR01 Syncra CRT-P C2TR01P010015/S580PMA supplement
2026-02-12Medtronic Cardiac Rhythm Disease ManagementAmplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D truncated in FDA recordP010031/S916PMA supplement
2026-02-12Medtronic, Inc.Aurora EV ICD DVEA3E4P220012/S067PMA supplement
2026-02-12Biosense Webster, Inc.VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)P240006/S014PMA supplement
2026-02-12Biotronik, Inc.Solia CSP S 53; Solia CSP S 60P950037/S280PMA supplement
2026-02-12Medtronic Cardiac Rhythm Disease ManagementEvera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD truncated in FDA recordP980016/S949PMA supplement
2026-02-11Biotronik, Inc.PHYLAX AV ICD SYSTEMP000009/S125PMA supplement
2026-02-11Medtronic 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/S914PMA supplement
2026-02-11Biotronik, Inc.TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADP050023/S205PMA supplement
2026-02-11Medtronic, Inc.Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac truncated in FDA recordP150033/S221PMA supplement

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