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.
| Date | Applicant | Device | Identifier | Kind |
|---|---|---|---|---|
| 2026-04-22 | Boston Scientific Corp | ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model truncated in FDA record | P010012/S606 | PMA supplement |
| 2026-04-22 | Medtronic, Inc. | Micra Transcatheter Pacing System | P150033/S225 | PMA supplement |
| 2026-04-22 | Boston Scientific | RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137); RELIANCE S Active Fix Single Coil IS-1/DF-1 64cm (Model 0 truncated in FDA record | P910073/S189 | PMA supplement |
| 2026-04-21 | RhythMedix, LLC | RhythmStar System (SL) | K250793 | 510(k) |
| 2026-04-21 | Boston Scientific Corp | Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425, truncated in FDA record | P010012/S594 | PMA supplement |
| 2026-04-21 | Medtronic, Inc. | Sphere-9 Catheter | P240013/S024 | PMA supplement |
| 2026-04-21 | Boston Scientific | Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120, truncated in FDA record | P960040/S507 | PMA supplement |
| 2026-04-17 | Biosense Webster, Inc. | QDOT MICRO™ System | P210027/S016 | PMA supplement |
| 2026-04-16 | ABBOTT MEDICAL | Volt™ PFA System | P250022/S003 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | Attain Bipolar OTW Lead; Attain OTW L V Lead | P010015/S586 | PMA supplement |
| 2026-04-15 | Medtronic Cardiac Rhythm Disease Management | Anchoring Sleeve Kit; SelectSecure Lead | P030036/S159 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead | P080006/S192 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | Myocardial Pacing Lead | P120017/S040 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | Epsila EV Extravascular Lead | P220012/S070 | PMA supplement |
| 2026-04-15 | Medtronic Cardiac Rhythm Disease Management | Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092); CapSure SP Novus Lead truncated in FDA record | P830061/S235 | PMA supplement |
| 2026-04-15 | Medtronic Cardiac Rhythm Disease Management | CapSure SP Novus Lead (5092); CapSure SP Novus Lead (5592); CapSure SP Novus Lead (5594); CapSure SP Z Lead, CapSure Z N truncated in FDA record | P850089/S174 | PMA supplement |
| 2026-04-15 | Medtronic Cardiac Rhythm Disease Management | End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925) | P900061/S176 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu truncated in FDA record | P920015/S305 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | CapSureFix Lead 5568, CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076) | P930039/S277 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | CapSure Epicardial Pacing Lead (4968), CapSure Epicardial Pacing Lead (4965) | P950024/S117 | PMA supplement |
| 2026-04-15 | Medtronic, Inc. | Transvene CS/SVC Lead (6937A) | P980050/S146 | PMA supplement |
| 2026-04-14 | Kestra Medical Technologies, Inc. | ASSURE Wearable Cardioverter Defibrillator (WCD) System | P200037/S019 | PMA supplement |
| 2026-04-13 | Medtronic, Inc. | PulseSelect Pulse Field Ablation (PFA) Catheter | P230017/S010 | PMA supplement |
| 2026-04-13 | ABBOTT MEDICAL | Volt™ PFA Catheter, Sensor Enabled™ | P250022/S004 | PMA supplement |
| 2026-04-10 | Boston Scientific Corp | Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode truncated in FDA record | P010012/S604 | PMA supplement |
| 2026-04-10 | Boston Scientific | • Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 • Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014 | P150012/S181 | PMA supplement |
| 2026-04-10 | Boston Scientific | Vein Pick Model 6541 | P830060/S092 | PMA supplement |
| 2026-04-10 | Boston Scientific | • ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S truncated in FDA record | P910073/S188 | PMA supplement |
| 2026-04-10 | Boston Scientific | Lead Port Plug Model 6996 | P910077/S197 | PMA supplement |
| 2026-04-10 | Boston Scientific | Wrench Kit Model 6501 | P930035/S036 | PMA supplement |
| 2026-04-10 | Boston Scientific | Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb truncated in FDA record | P960004/S114 | PMA supplement |
| 2026-04-10 | Boston Scientific | Fixation Tool Model 6616 | P960006/S058 | PMA supplement |
| 2026-04-09 | ABBOTT MEDICAL | FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) | P110016/S093 | PMA supplement |
| 2026-04-03 | ABBOTT MEDICAL | AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201) | P150035/S036 | PMA supplement |
| 2026-04-02 | Medtronic, Inc. | Sphere-9 Catheter; Tubing Set; Extension Cable | P240013/S023 | PMA supplement |
| 2026-04-02 | Biotronik, Inc. | Solia CSP S Leads | P950037/S288 | PMA supplement |
| 2026-04-01 | Boston Scientific Corp | PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE | N970003/S306 | PMA supplement |
| 2026-04-01 | Boston Scientific Corp | CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL truncated in FDA record | P010012/S605 | PMA supplement |
| 2026-04-01 | Guidant Corp. | CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE | P030005/S252 | PMA supplement |
| 2026-04-01 | Boston Scientific | VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM truncated in FDA record | P960040/S512 | PMA supplement |
| 2026-03-30 | Biotronik, Inc. | Amvia-Solvia Pulse Generators Scan Duration Extension | P950037/S282 | PMA supplement |
| 2026-03-27 | Medtronic, Inc. | Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P truncated in FDA record | P010015/S584 | PMA supplement |
| 2026-03-27 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D | P010031/S921 | PMA supplement |
| 2026-03-27 | ABBOTT MEDICAL | Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( truncated in FDA record | P030054/S443 | PMA supplement |
| 2026-03-27 | EBR Systems, Inc. | WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System | P240028/S006 | PMA supplement |
| 2026-03-27 | ABBOTT MEDICAL | Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C truncated in FDA record | P910023/S485 | PMA supplement |
| 2026-03-27 | Biotronik, Inc. | Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T truncated in FDA record | P950037/S287 | PMA supplement |
| 2026-03-27 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD | P980016/S954 | PMA supplement |
| 2026-03-23 | ABBOTT MEDICAL | Volt PFA Catheter Sensor Enabled™ | P250022/S001 | PMA supplement |
| 2026-03-20 | Medtronic, Inc. | Sphere-9 Catheter (AFR-00001) | P240013/S021 | PMA supplement |
Source: openFDA device/510k and device/pma, verified rows only, as the FDA names each applicant and device; last verified 20 September 2026.