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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
2026-05-15Medtronic, Inc.Sphere-9 Catheter and Affera Ablation SystemP240013/S025PMA supplement
2026-05-15Boston ScientificVein Pick (Model 6541)P830060/S093PMA supplement
2026-05-15Boston ScientificACUITY™ X4 Connector Tool (Model 4625); RELIANCE™ 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit truncated in FDA recordP910073/S190PMA supplement
2026-05-15Boston ScientificDF-1 Plug (Model 6996)P910077/S199PMA supplement
2026-05-15Boston ScientificHex Wrench (#2) (Model 6501)P930035/S037PMA supplement
2026-05-15Biotronik, Inc.Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker ElectrodesP950037/S292PMA supplement
2026-05-15Boston ScientificStylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606 truncated in FDA recordP960004/S115PMA supplement
2026-05-15Boston ScientificFixation Tool (Model 6616)P960006/S059PMA supplement
2026-05-15Medtronic 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/S958PMA supplement
2026-05-14Medtronic, Inc.Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar truncated in FDA recordP010015/S583PMA supplement
2026-05-13Medtronic, Inc.Sphere-9™ Mapping and Ablation Catheter; Tubing Set; Extension CableP240013/S027PMA supplement
2026-05-08Medtronic, Inc.Micra Cathode Press Station 2P150033/S227PMA supplement
2026-05-07Biotronik, Inc.Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-TP000009/S129PMA supplement
2026-05-07Biotronik, Inc.Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, truncated in FDA recordP050023/S210PMA supplement
2026-05-07Biotronik, Inc.Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Amvia Sky HF-T, Amvia Sky truncated in FDA recordP070008/S178PMA supplement
2026-05-07Biotronik, Inc.Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 SR-T, Evity 8 S truncated in FDA recordP950037/S290PMA supplement
2026-05-07Biotronik, 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 truncated in FDA recordP980023/S145PMA supplement
2026-05-06AtriCure, Inc.Synergy Ablation SystemP100046/S020PMA supplement
2026-05-06AtriCure, Inc.EPi-Sense and EPi-Sense ST Guided Coagulation SystemP200002/S014PMA supplement
2026-05-06Farapulse, Inc.FARAPULSE™ Pulsed Field Ablation SystemP230030/S019PMA supplement
2026-05-01Biotronik, Inc.BIOMONITOR IV (471155)K261074510(k)
2026-04-30Medtronic, Inc.Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar truncated in FDA recordP010015/S581PMA supplement
2026-04-30Medtronic Cardiac Rhythm Disease ManagementCobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M truncated in FDA recordP010031/S918PMA supplement
2026-04-30Medtronic 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/S924PMA supplement
2026-04-30Medtronic, Inc.Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)P150033/S223PMA supplement
2026-04-30Medtronic, Inc.Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra VR2 TPSP150033/S226PMA supplement
2026-04-30Medtronic, Inc.Aurora EV-ICDP220012/S072PMA supplement
2026-04-30Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC truncated in FDA recordP980016/S951PMA supplement
2026-04-30Medtronic 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/S957PMA supplement
2026-04-28Medtronic 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/S923PMA supplement
2026-04-28Medtronic, Inc.Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICDP220012/S071PMA supplement
2026-04-28Medtronic Cardiac Rhythm Disease ManagementEvera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, truncated in FDA recordP980016/S956PMA supplement
2026-04-24Biotronik, Inc.Renamic NeoP000009/S127PMA supplement
2026-04-24ABBOTT MEDICALAnthem, Allure/RF, Allure Quadra/RF family of CRT-PsP030035/S212PMA supplement
2026-04-24ABBOTT MEDICALPromote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ truncated in FDA recordP030054/S442PMA supplement
2026-04-24ABBOTT MEDICALOptisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q truncated in FDA recordP030054/S444PMA supplement
2026-04-24Biotronik, Inc.Renamic NeoP050023/S207PMA supplement
2026-04-24Biotronik, Inc.Renamic NeoP070008/S175PMA supplement
2026-04-24ABBOTT MEDICALAssurity MRI, Endurity MRI family of PacemakersP140033/S102PMA supplement
2026-04-24ABBOTT MEDICALAveir Leadless SystemP150035/S037PMA supplement
2026-04-24Medtronic, Inc.OmniaSecure™ MRI SureScan™ Lead Model 3930MP240036/S005PMA supplement
2026-04-24Medtronic, Inc.OmniaSecure™ MRI SureScan™ Lead Model 3930MP240036/S006PMA supplement
2026-04-24ABBOTT MEDICALAssurity, Assurity+, Endurity, Accent family of PacemakersP880086/S346PMA supplement
2026-04-24ABBOTT MEDICALCurrent, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDsP910023/S484PMA supplement
2026-04-24ABBOTT MEDICALDurata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q)P950022/S152PMA supplement
2026-04-24Biotronik, Inc.Renamic NeoP950037/S285PMA supplement
2026-04-23Cortex, Inc.OptiMap Catheter - 60mm (OPTI-CATH2-60)K261012510(k)
2026-04-23Medtronic, Inc.Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C truncated in FDA recordP010015/S585PMA supplement
2026-04-23Medtronic Cryocath, LPFreezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5P020045/S113PMA supplement
2026-04-23Medtronic Cryocath, LPFreezor MAX 209F3,209F5P100010/S153PMA supplement

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