431 décisions de la FDA, avec le dossier de la FDA en lien

20 autorisations 510(k) (notification préalable à la mise en marché) et 411 décisions de PMA (approbation préalable à la mise en marché) visant des instruments d’électrophysiologie, de la plus récente à la plus ancienne. L’identifiant renvoie au dossier de la FDA.

Date	Demandeur	Instrument	Identifiant	Type
2026-09-04	Peerbridge Health, Inc.	Peerbridge COR MDx (Cor MDx)	K253529	510(k)
2026-09-04	Farapulse, Inc.	FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul tronqué dans le dossier de la FDA	P230030/S024	PMA supplement
2026-09-03	Irvine Biomedical, Inc.	Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation Catheter	P040014/S052	PMA supplement
2026-09-03	Irvine Biomedical,Inc.(Ibi)	Therapy™ Dual-8™ Ablation Catheter	P040042/S060	PMA supplement
2026-09-02	Biosense Webster, Inc.	THERMOCOOL SMARTTOUCH® SF Catheter	P030031/S142	PMA supplement
2026-08-28	Medtronic, Inc.	LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)	K262735	510(k)
2026-08-27	Stereotaxis, Inc.	GenesisX RMN	K262744	510(k)
2026-08-27	ABBOTT MEDICAL	Aveir VR Leadless System	P150035/S041	PMA supplement
2026-08-27	Biotronik, Inc.	Solia CSP S	P950037/S297	PMA supplement
2026-08-25	Boston Scientific Corp	Tachy Pulse Generators	P010012/S612	PMA supplement
2026-08-25	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, tronqué dans le dossier de la FDA	P230030/S016	PMA supplement
2026-08-25	Boston Scientific	Tachy Pulse Generators	P960040/S515	PMA supplement
2026-08-20	Kardium, Inc.	Globe® Catheter Laminated Ribs	P240044/S006	PMA supplement
2026-08-19	Medtronic, Inc.	MEDTRONIC(R) TRANSVENE LEAD SYSTEM	P920015/S307	PMA supplement
2026-08-17	Biosense Webster, Inc.	TX eco Cable	P210027/S017	PMA supplement
2026-08-14	Schiller AG	medilogFD	K253562	510(k)
2026-08-12	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q, tronqué dans le dossier de la FDA	P030054/S446	PMA supplement
2026-08-12	ABBOTT MEDICAL	Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA600T, tronqué dans le dossier de la FDA	P910023/S487	PMA supplement
2026-08-11	ABBOTT MEDICAL	Volt™ PFA Catheter, Sensor Enabled™	P250022/S008	PMA supplement
2026-08-07	Irvine Biomedical, Inc.	Ampere Generator	P040014/S051	PMA supplement
2026-08-07	Irvine Biomedical,Inc.(Ibi)	Ampere Generator	P040042/S059	PMA supplement
2026-08-07	Irvine Biomedical, Inc.	Ampere Generator	P060019/S059	PMA supplement
2026-08-07	ABBOTT MEDICAL	Ampere Generator	P110016/S095	PMA supplement
2026-08-07	St Jude Medical	TactiSys Quartz Equipment; Ampere Generator	P130026/S102	PMA supplement
2026-08-07	ABBOTT MEDICAL	TactiSys Quartz Equipment; Ampere Generator	P220013/S033	PMA supplement
2026-08-07	St Jude Medical	Ampere Generator	P960016/S094	PMA supplement
2026-08-06	Medtronic Cryocath, LP	Stop AF First	P100010/S152	PMA supplement
2026-08-06	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System	P230030/S018	PMA supplement
2026-08-06	Medtronic, Inc.	Sphere-9 Catheter AFR-00001	P240013/S030	PMA supplement
2026-08-05	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead 3830	P030036/S161	PMA supplement
2026-08-04	Medtronic, Inc.	Sphere-9 Catheter and Affera Ablation System	P240013/S029	PMA supplement
2026-07-31	Medtronic, Inc.	Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T tronqué dans le dossier de la FDA	P010015/S588	PMA supplement
2026-07-31	Medtronic, Inc.	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar tronqué dans le dossier de la FDA	P010015/S589	PMA supplement
2026-07-31	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 tronqué dans le dossier de la FDA	P010031/S928	PMA supplement
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR tronqué dans le dossier de la FDA	P010031/S929	PMA supplement
2026-07-31	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 tronqué dans le dossier de la FDA	P010031/S930	PMA supplement
2026-07-31	Medtronic, Inc.	Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)	P150033/S228	PMA supplement
2026-07-31	Medtronic, Inc.	Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)	P150033/S229	PMA supplement
2026-07-31	Medtronic, Inc.	Aurora EV ICD (DVEA3E4)	P220012/S074	PMA supplement
2026-07-31	Medtronic, Inc.	Aurora EV-ICD (DVEA3E4)	P220012/S075	PMA supplement
2026-07-31	Stereotaxis, Inc.	MAGiC Ablation Catheter	P240014/S001	PMA supplement
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I tronqué dans le dossier de la FDA	P980016/S961	PMA supplement
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I tronqué dans le dossier de la FDA	P980016/S962	PMA supplement
2026-07-31	Medtronic Cardiac Rhythm Disease Management	Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR tronqué dans le dossier de la FDA	P980016/S963	PMA supplement
2026-07-30	Swift Sync, Inc.	Sync AV II Temporary Pacing Catheter	K252042	510(k)
2026-07-30	Zoll Manufacturing Corporation	LifeVest® Wearable Defibrillator	P010030/S202	PMA supplement
2026-07-24	Boston Scientific Corporation	FARADRIVE™ Steerable Sheath (M004PF21M402)	K262165	510(k)
2026-07-23	Boston Scientific Corp	ESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201) tronqué dans le dossier de la FDA	N970003/S309	PMA supplement
2026-07-23	Boston Scientific Corp	MOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138 tronqué dans le dossier de la FDA	P010012/S613	PMA supplement
2026-07-23	Guidant Corp.	VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U tronqué dans le dossier de la FDA	P030005/S255	PMA supplement

Source : openFDA device/510k et device/pma, lignes vérifiées seulement, chaque demandeur et instrument tels que la FDA les nomme ; dernière vérification le 24 septembre 2026.