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 |
|---|---|---|---|---|
| 2026-07-23 | Boston Scientific Corporation | S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219) | P110042/S215 | PMA supplement |
| 2026-07-23 | Boston Scientific | ESSENTIO™ MRI SR SL (L110); ESSENTIO™ MRI DR SL (L111); ESSENTIO™ MRI DR EL (L131); PROPONENT™ MRI SR SL (L210); PROPONE truncated in FDA record | P150012/S189 | PMA supplement |
| 2026-07-23 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C truncated in FDA record | P220013/S030 | PMA supplement |
| 2026-07-23 | ABBOTT MEDICAL | Current™ PFA Generator – TactiFlex Duo | P250022/S005 | PMA supplement |
| 2026-07-23 | Boston Scientific | ICD INOGEN™ VR DF4 (D010); ICD INOGEN™ VR DF1/IS1 (D011); ICD INOGEN™ DR DF4/IS1 (D012); ICD INOGEN™ DR DF1/IS1 (D013); truncated in FDA record | P960040/S516 | PMA supplement |
| 2026-07-22 | Medtronic Cardiac Rhythm Disease Management | Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRTD DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D1, DTBC1D4; Brava Quad CRT-D truncated in FDA record | P010031/S927 | PMA supplement |
| 2026-07-22 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D truncated in FDA record | P980016/S960 | PMA supplement |
| 2026-07-21 | ABBOTT MEDICAL | Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps | P030035/S211 | PMA supplement |
| 2026-07-21 | ABBOTT MEDICAL | Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ truncated in FDA record | P030054/S440 | PMA supplement |
| 2026-07-21 | ABBOTT MEDICAL | Assurity MRI / Endurity MRI Pacemakers | P140033/S101 | PMA supplement |
| 2026-07-21 | ABBOTT MEDICAL | Aveir™ Leadless System | P150035/S035 | PMA supplement |
| 2026-07-21 | ABBOTT MEDICAL | Assurity, Assurity+, Endurity, Accent family of Pacemakers | P880086/S345 | PMA supplement |
| 2026-07-21 | ABBOTT MEDICAL | Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs | P910023/S482 | PMA supplement |
| 2026-07-16 | 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/S587 | PMA supplement |
| 2026-07-16 | Medtronic Cardiac Rhythm Disease Management | Amplia 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 record | P010031/S926 | PMA supplement |
| 2026-07-16 | Kestra Medical Technologies, Inc. | ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) | P200037/S020 | PMA supplement |
| 2026-07-16 | Medtronic, Inc. | Aurora EV ICD | P220012/S073 | PMA supplement |
| 2026-07-16 | Medtronic Cardiac Rhythm Disease Management | Evera 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 record | P980016/S959 | PMA supplement |
| 2026-07-10 | Farapulse, Inc. | FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) | P230030/S022 | PMA supplement |
| 2026-07-10 | Medtronic, Inc. | HexaGen RF Generator Software and Remote | P240013/S026 | PMA supplement |
| 2026-07-10 | ABBOTT MEDICAL | Volt™ PFA System | P250022/S006 | PMA supplement |
| 2026-07-09 | ABBOTT MEDICAL | Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q, CDHFA600T, truncated in FDA record | P030054/S445 | PMA supplement |
| 2026-07-09 | ABBOTT MEDICAL | Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); truncated in FDA record | P910023/S486 | PMA supplement |
| 2026-07-07 | Boston Scientific Corporation | EMBLEM™ S-ICD Electrode (Lead) Model 3501 | P110042/S210 | PMA supplement |
| 2026-07-01 | Boston Scientific Corp | ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 | N970003/S307 | PMA supplement |
| 2026-07-01 | Boston Scientific Corp | COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT | P010012/S607 | PMA supplement |
| 2026-07-01 | Guidant Corp. | INVIVE, INTUA, VISIONIST, VALITUDE | P030005/S253 | PMA supplement |
| 2026-07-01 | Biosense Webster, Inc. | Dual Energy THERMOCOOL SMARTTOUCH SF™ System | P030031/S141 | PMA supplement |
| 2026-07-01 | Boston Scientific Corporation | EMBLEM S-ICD | P110042/S211 | PMA supplement |
| 2026-07-01 | Boston Scientific Corporation | Emblem S-ICD (A209); Emblem MRI S-ICD (A219) | P110042/S214 | PMA supplement |
| 2026-07-01 | Boston Scientific | INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI | P150012/S182 | PMA supplement |
| 2026-07-01 | Boston Scientific | LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460 | P910077/S198 | PMA supplement |
| 2026-07-01 | Biotronik, Inc. | Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60 | P950037/S295 | PMA supplement |
| 2026-07-01 | Boston Scientific | TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA | P960040/S513 | PMA supplement |
| 2026-07-01 | Biotronik, Inc. | Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 truncated in FDA record | P980023/S148 | PMA supplement |
| 2026-06-30 | Biosense Webster, Inc. | VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System | P030031/S143 | PMA supplement |
| 2026-06-30 | Medtronic, Inc. | PulseSelect Pulse Field Ablation (PFA) Catheter | P230017/S011 | PMA supplement |
| 2026-06-30 | Biosense Webster, Inc. | VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU) | P240006/S016 | PMA supplement |
| 2026-06-26 | Edwards Lifesciences | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | K254232 | 510(k) |
| 2026-06-26 | Farapulse, Inc. | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, truncated in FDA record | P230030/S023 | PMA supplement |
| 2026-06-26 | ABBOTT MEDICAL | Durata Leads; Optisure Leads; UltiSync Leads | P950022/S154 | PMA supplement |
| 2026-06-26 | ABBOTT MEDICAL | Tendril STS Leads; Ultipace Leads; Optisense Leads | P960013/S134 | PMA supplement |
| 2026-06-26 | ABBOTT MEDICAL | IsoFlex Leads | P960030/S085 | PMA supplement |
| 2026-06-25 | Seers Technology Co., Ltd. | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | K253384 | 510(k) |
| 2026-06-25 | Medtronic Cardiac Rhythm Disease Management | Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1, DTBC1QQ Cl truncated in FDA record | P010031/S922 | PMA supplement |
| 2026-06-25 | Medtronic, Inc. | Aurora EV ICD DVEA3E4 | P220012/S069 | PMA supplement |
| 2026-06-25 | Medtronic Cardiac Rhythm Disease Management | Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M truncated in FDA record | P980016/S955 | PMA supplement |
| 2026-06-24 | Biotronik, Inc. | Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014) | P000009/S131 | PMA supplement |
| 2026-06-24 | Medtronic Cardiac Rhythm Disease Management | SelectSecure Lead (3830) | P030036/S160 | PMA supplement |
| 2026-06-24 | Biotronik, Inc. | Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574); Rivacor 5 VR-T DF4 P truncated in FDA record | P050023/S212 | 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.