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 |
|---|---|---|---|---|
| 2026-06-24 | Medtronic, Inc. | Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability truncated in FDA record | P080006/S193 | PMA supplement |
| 2026-06-24 | Medtronic Cardiac Rhythm Disease Management | CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) | P830061/S236 | PMA supplement |
| 2026-06-24 | Medtronic, Inc. | Sprint Quattro Lead (6946M) | P920015/S306 | PMA supplement |
| 2026-06-24 | Medtronic, Inc. | CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B) | P930039/S278 | PMA supplement |
| 2026-06-24 | Biotronik, 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 record | P980023/S147 | PMA supplement |
| 2026-06-23 | Kardium, Inc. | Globe® Catheter and Globe® Pulsed Field System | P240044/S001 | PMA supplement |
| 2026-06-22 | ABBOTT MEDICAL | VOLT™ PFA CATHETER, SENSOR ENABLED™ | P250022/S007 | PMA supplement |
| 2026-06-18 | Zywie, Inc. | ZywieZ3 Sensor & Adhesive | K252839 | 510(k) |
| 2026-06-17 | ABBOTT MEDICAL | AVEIR Patient Transmitter LSRM01 | P150035/S040 | PMA supplement |
| 2026-06-12 | Kardium, Inc. | Globe® Catheter; Globe® Pulsed Field System | P240044/S005 | PMA supplement |
| 2026-06-11 | ABBOTT MEDICAL | The AVEIR Leadless Pacemaker (LP) | P150035/S039 | PMA supplement |
| 2026-06-11 | ABBOTT MEDICAL | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten truncated in FDA record | P960013/S133 | PMA supplement |
| 2026-06-11 | ABBOTT MEDICAL | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten truncated in FDA record | P960030/S084 | PMA supplement |
| 2026-06-10 | Biosense Webster, Inc. | THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS | P030031/S144 | PMA supplement |
| 2026-06-09 | Boston Scientific Corp | ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L | P010012/S611 | PMA supplement |
| 2026-06-09 | Boston Scientific | LD INGEVITY™ PLUS AF | P150012/S188 | PMA supplement |
| 2026-06-09 | Boston Scientific | RELIANCE™ S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual truncated in FDA record | P910073/S192 | PMA supplement |
| 2026-06-05 | ABBOTT MEDICAL | FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM | P110016/S094 | PMA supplement |
| 2026-06-05 | St Jude Medical | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | P130026/S100 | PMA supplement |
| 2026-06-05 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ | P220013/S031 | PMA supplement |
| 2026-06-05 | Farapulse, Inc. | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, truncated in FDA record | P230030/S021 | PMA supplement |
| 2026-06-04 | Medtronic, Inc. | Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS truncated in FDA record | P150033/S224 | PMA supplement |
| 2026-06-03 | Boston Scientific Corp | ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE | N970003/S308 | PMA supplement |
| 2026-06-03 | Boston Scientific Corp | MOMENTUM, MOMENTUM X4, INOGEN, DYNAGEN, VIGILANT, VIGILANT X4, RESONATE, RESONATE X4, RESONATE HF | P010012/S609 | PMA supplement |
| 2026-06-03 | Boston Scientific Corp | EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467 truncated in FDA record | P010012/S610 | PMA supplement |
| 2026-06-03 | Guidant Corp. | VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 | P030005/S254 | PMA supplement |
| 2026-06-03 | Boston Scientific Corporation | EMBLEM, EMBLEM MRI | P110042/S212 | PMA supplement |
| 2026-06-03 | Boston Scientific Corporation | S-ICD Electrode Model: 3501 | P110042/S213 | PMA supplement |
| 2026-06-03 | Boston Scientific | ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI | P150012/S185 | PMA supplement |
| 2026-06-03 | Boston Scientific | Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832 truncated in FDA record | P150012/S186 | PMA supplement |
| 2026-06-03 | Boston Scientific | Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266 truncated in FDA record | P910073/S191 | PMA supplement |
| 2026-06-03 | Boston Scientific | ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480 | P960004/S116 | PMA supplement |
| 2026-06-03 | Boston Scientific | INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF | P960040/S514 | PMA supplement |
| 2026-06-01 | Boston Scientific | INGEVITYTM+ Lead Passive Models | P150012/S187 | PMA supplement |
| 2026-05-29 | St Jude Medical | TactiCath™ Ablation Catheter, Sensor Enabled™ (TactiCath™ SE) | P130026/S101 | PMA supplement |
| 2026-05-29 | ABBOTT MEDICAL | Aveir VR (LSCD111); DR Delivery Catheter (LSCD201) | P150035/S038 | PMA supplement |
| 2026-05-29 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex™ SE) | P220013/S032 | PMA supplement |
| 2026-05-29 | Boston Scientific Corporation | POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console truncated in FDA record | P220032/S012 | PMA supplement |
| 2026-05-28 | Medtronic Cardiac Rhythm Disease Management | SelectSecure Lead Model 3830 | P030036/S158 | PMA supplement |
| 2026-05-28 | ABBOTT MEDICAL | TactiFlex™ Sensor Enabled™ Ablation Catheter | P220013/S022 | PMA supplement |
| 2026-05-28 | Medtronic, Inc. | Affera Ablation System | P240013/S022 | PMA supplement |
| 2026-05-28 | Biotronik, Inc. | Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie truncated in FDA record | P950037/S293 | PMA supplement |
| 2026-05-22 | Genesee Biomedical, Inc. | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | K252917 | 510(k) |
| 2026-05-19 | Boston Scientific | INGEVITY™ MRI; INGEVITY™+; INGEVITY™+ Passive | P150012/S184 | PMA supplement |
| 2026-05-15 | Boston Scientific Corp | ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604) | P010012/S608 | PMA supplement |
| 2026-05-15 | Zoll Manufacturing Corporation | LifeVest® Wearable Defibrillator | P010030/S200 | PMA supplement |
| 2026-05-15 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Cobalt X truncated in FDA record | P010031/S925 | PMA supplement |
| 2026-05-15 | St Jude Medical | TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- truncated in FDA record | P130026/S099 | PMA supplement |
| 2026-05-15 | Boston Scientific | Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY™ Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402 truncated in FDA record | P150012/S183 | PMA supplement |
| 2026-05-15 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF; A-TFSE-FJ; truncated in FDA record | P220013/S029 | 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.