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 |
|---|---|---|---|---|
| 2026-01-08 | St Jude Medical | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) | P130026/S097 | PMA supplement |
| 2026-01-08 | Boston Scientific | Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: truncated in FDA record | P150012/S169 | PMA supplement |
| 2026-01-08 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) | P220013/S025 | PMA supplement |
| 2026-01-08 | Boston Scientific | NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG truncated in FDA record | P960040/S505 | PMA supplement |
| 2026-01-06 | Kardium, Inc. | Globe® Pulsed Field System | P240044/S003 | PMA supplement |
| 2026-01-05 | Medtronic Cardiac Rhythm Disease Management | Amplia 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 record | P010031/S911 | PMA supplement |
| 2026-01-05 | Medtronic, Inc. | Aurora EV ICD DVEA3E4 | P220012/S063 | PMA supplement |
| 2026-01-05 | Stereotaxis, Inc. | MAGiC Ablation Catheter | P240014 | PMA supplement |
| 2026-01-05 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP truncated in FDA record | P980016/S944 | PMA supplement |
| 2026-01-02 | Biosense Webster, Inc. | VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump | P240006/S013 | PMA supplement |
| 2025-12-08 | Heartbeam, Inc. | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | K250258 | 510(k) |
| 2025-12-05 | Huinno Co., Ltd. | MEMO Patch M (MPT-E08R-UNC01) | K243438 | 510(k) |
| 2025-11-26 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | K252405 | 510(k) |
Source: openFDA device/510k and device/pma, verified rows only, as the FDA names each applicant and device; last verified 20 September 2026.