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
2026-04-22	Boston Scientific Corp	ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model tronqué dans le dossier de la FDA	P010012/S606	PMA supplement
2026-04-22	Medtronic, Inc.	Micra Transcatheter Pacing System	P150033/S225	PMA supplement
2026-04-22	Boston Scientific	RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137); RELIANCE S Active Fix Single Coil IS-1/DF-1 64cm (Model 0 tronqué dans le dossier de la FDA	P910073/S189	PMA supplement
2026-04-21	RhythMedix, LLC	RhythmStar System (SL)	K250793	510(k)
2026-04-21	Boston Scientific Corp	Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425, tronqué dans le dossier de la FDA	P010012/S594	PMA supplement
2026-04-21	Medtronic, Inc.	Sphere-9 Catheter	P240013/S024	PMA supplement
2026-04-21	Boston Scientific	Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120, tronqué dans le dossier de la FDA	P960040/S507	PMA supplement
2026-04-17	Biosense Webster, Inc.	QDOT MICRO™ System	P210027/S016	PMA supplement
2026-04-16	ABBOTT MEDICAL	Volt™ PFA System	P250022/S003	PMA supplement
2026-04-15	Medtronic, Inc.	Attain Bipolar OTW Lead; Attain OTW L V Lead	P010015/S586	PMA supplement
2026-04-15	Medtronic Cardiac Rhythm Disease Management	Anchoring Sleeve Kit; SelectSecure Lead	P030036/S159	PMA supplement
2026-04-15	Medtronic, Inc.	Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead	P080006/S192	PMA supplement
2026-04-15	Medtronic, Inc.	Myocardial Pacing Lead	P120017/S040	PMA supplement
2026-04-15	Medtronic, Inc.	Epsila EV Extravascular Lead	P220012/S070	PMA supplement
2026-04-15	Medtronic Cardiac Rhythm Disease Management	Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092); CapSure SP Novus Lead tronqué dans le dossier de la FDA	P830061/S235	PMA supplement
2026-04-15	Medtronic Cardiac Rhythm Disease Management	CapSure SP Novus Lead (5092); CapSure SP Novus Lead (5592); CapSure SP Novus Lead (5594); CapSure SP Z Lead, CapSure Z N tronqué dans le dossier de la FDA	P850089/S174	PMA supplement
2026-04-15	Medtronic Cardiac Rhythm Disease Management	End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925)	P900061/S176	PMA supplement
2026-04-15	Medtronic, Inc.	ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu tronqué dans le dossier de la FDA	P920015/S305	PMA supplement
2026-04-15	Medtronic, Inc.	CapSureFix Lead 5568, CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076)	P930039/S277	PMA supplement
2026-04-15	Medtronic, Inc.	CapSure Epicardial Pacing Lead (4968), CapSure Epicardial Pacing Lead (4965)	P950024/S117	PMA supplement
2026-04-15	Medtronic, Inc.	Transvene CS/SVC Lead (6937A)	P980050/S146	PMA supplement
2026-04-14	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	P200037/S019	PMA supplement
2026-04-13	Medtronic, Inc.	PulseSelect Pulse Field Ablation (PFA) Catheter	P230017/S010	PMA supplement
2026-04-13	ABBOTT MEDICAL	Volt™ PFA Catheter, Sensor Enabled™	P250022/S004	PMA supplement
2026-04-10	Boston Scientific Corp	Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode tronqué dans le dossier de la FDA	P010012/S604	PMA supplement
2026-04-10	Boston Scientific	• Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 • Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014	P150012/S181	PMA supplement
2026-04-10	Boston Scientific	Vein Pick Model 6541	P830060/S092	PMA supplement
2026-04-10	Boston Scientific	• ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S tronqué dans le dossier de la FDA	P910073/S188	PMA supplement
2026-04-10	Boston Scientific	Lead Port Plug Model 6996	P910077/S197	PMA supplement
2026-04-10	Boston Scientific	Wrench Kit Model 6501	P930035/S036	PMA supplement
2026-04-10	Boston Scientific	Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb tronqué dans le dossier de la FDA	P960004/S114	PMA supplement
2026-04-10	Boston Scientific	Fixation Tool Model 6616	P960006/S058	PMA supplement
2026-04-09	ABBOTT MEDICAL	FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE)	P110016/S093	PMA supplement
2026-04-03	ABBOTT MEDICAL	AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201)	P150035/S036	PMA supplement
2026-04-02	Medtronic, Inc.	Sphere-9 Catheter; Tubing Set; Extension Cable	P240013/S023	PMA supplement
2026-04-02	Biotronik, Inc.	Solia CSP S Leads	P950037/S288	PMA supplement
2026-04-01	Boston Scientific Corp	PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE	N970003/S306	PMA supplement
2026-04-01	Boston Scientific Corp	CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL tronqué dans le dossier de la FDA	P010012/S605	PMA supplement
2026-04-01	Guidant Corp.	CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE	P030005/S252	PMA supplement
2026-04-01	Boston Scientific	VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM tronqué dans le dossier de la FDA	P960040/S512	PMA supplement
2026-03-30	Biotronik, Inc.	Amvia-Solvia Pulse Generators Scan Duration Extension	P950037/S282	PMA supplement
2026-03-27	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/S584	PMA supplement
2026-03-27	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	P010031/S921	PMA supplement
2026-03-27	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( tronqué dans le dossier de la FDA	P030054/S443	PMA supplement
2026-03-27	EBR Systems, Inc.	WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System	P240028/S006	PMA supplement
2026-03-27	ABBOTT MEDICAL	Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C tronqué dans le dossier de la FDA	P910023/S485	PMA supplement
2026-03-27	Biotronik, Inc.	Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T tronqué dans le dossier de la FDA	P950037/S287	PMA supplement
2026-03-27	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD	P980016/S954	PMA supplement
2026-03-23	ABBOTT MEDICAL	Volt PFA Catheter Sensor Enabled™	P250022/S001	PMA supplement
2026-03-20	Medtronic, Inc.	Sphere-9 Catheter (AFR-00001)	P240013/S021	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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