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

22 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 ouvre la page de dossier, qui renvoie au dossier de la FDA.

Date	Demandeur	Instrument	Identifiant	Type
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 tronqué dans le dossier de la FDA	P150012/S189	PMA supplement
2026-07-23	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C tronqué dans le dossier de la FDA	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); tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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+ tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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, tronqué dans le dossier de la FDA	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, tronqué dans le dossier de la FDA	P030054/S445	PMA supplement
2026-07-09	ABBOTT MEDICAL	Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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, tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	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 tronqué dans le dossier de la FDA	P050023/S212	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.

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