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
2026-02-11	Medtronic, Inc.	Aurora EV ICD	P220012/S065	PMA supplement
2026-02-11	Biotronik, Inc.	DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS	P950037/S283	PMA supplement
2026-02-11	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; Mirro tronqué dans le dossier de la FDA	P980016/S947	PMA supplement
2026-02-11	Biotronik, Inc.	PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	P980023/S142	PMA supplement
2026-02-10	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/S578	PMA supplement
2026-02-10	Medtronic, Inc.	Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua tronqué dans le dossier de la FDA	P010015/S579	PMA supplement
2026-02-10	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/S915	PMA supplement
2026-02-10	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead	P030036/S156	PMA supplement
2026-02-10	Medtronic, Inc.	Attain StarFix Lead	P060039/S119	PMA supplement
2026-02-10	Medtronic, Inc.	Micra AV2 TPS; Micra VR2 TPS	P150033/S220	PMA supplement
2026-02-10	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S066	PMA supplement
2026-02-10	Medtronic Cardiac Rhythm Disease Management	CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen tronqué dans le dossier de la FDA	P830061/S233	PMA supplement
2026-02-10	Medtronic Cardiac Rhythm Disease Management	CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB	P850089/S173	PMA supplement
2026-02-10	Medtronic, Inc.	HV Splitter/Adaptor kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 tronqué dans le dossier de la FDA	P920015/S302	PMA supplement
2026-02-10	Medtronic, Inc.	CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall tronqué dans le dossier de la FDA	P930039/S275	PMA supplement
2026-02-10	Medtronic, Inc.	CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968)	P950024/S116	PMA supplement
2026-02-10	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/S948	PMA supplement
2026-02-03	Biotronik, Inc.	PHYLAX AV ICD SYSTEM	P000009/S126	PMA supplement
2026-02-03	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD	P050023/S206	PMA supplement
2026-02-03	Biotronik, Inc.	STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD	P070008/S174	PMA supplement
2026-02-03	ABBOTT MEDICAL	TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T tronqué dans le dossier de la FDA	P220013/S027	PMA supplement
2026-02-03	Biotronik, Inc.	DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS	P950037/S284	PMA supplement
2026-02-03	Biotronik, Inc.	PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	P980023/S143	PMA supplement
2026-01-29	Zoll Manufacturing Corporation	LifeVest® Wearable Defibrillator	P010030/S199	PMA supplement
2026-01-23	Boston Scientific Cardiac Diagnostic Technologies, Inc.	BodyGuardian Remote Monitoring System (BGRMS v3.0)	K243349	510(k)
2026-01-23	Medtronic, Inc.	Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar tronqué dans le dossier de la FDA	P010015/S576	PMA supplement
2026-01-23	Medtronic, Inc.	Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P tronqué dans le dossier de la FDA	P010015/S577	PMA supplement
2026-01-23	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/S912	PMA supplement
2026-01-23	Medtronic, Inc.	Aurora EV-ICD System	P220012/S064	PMA supplement
2026-01-23	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve tronqué dans le dossier de la FDA	P980016/S945	PMA supplement
2026-01-16	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	P010031/S913	PMA supplement
2026-01-16	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD	P980016/S946	PMA supplement
2026-01-15	Irvine Biomedical,Inc.(Ibi)	Safire™ TX Bi-directional and Therapy™ Dual-8™	P040042/S058	PMA supplement
2026-01-15	ABBOTT MEDICAL	FlexAbility™ and FlexAbility™ Sensor Enabled™	P110016/S092	PMA supplement
2026-01-15	MicroPort CRM USA, Inc.	VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)	P130010/S005	PMA supplement
2026-01-15	St Jude Medical	TactiCath™ Sensor Enabled™	P130026/S098	PMA supplement
2026-01-15	ABBOTT MEDICAL	TactiFlex™ Sensor Enabled™	P220013/S026	PMA supplement
2026-01-15	St Jude Medical	Livewire™ TC XLS™	P960016/S093	PMA supplement
2026-01-13	Element Science, Inc.	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati tronqué dans le dossier de la FDA	P230022/S006	PMA supplement
2026-01-13	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)	P230030/S017	PMA supplement
2026-01-12	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C tronqué dans le dossier de la FDA	P230030/S012	PMA supplement
2026-01-09	Boston Scientific	INGEVITY™ Family Bradycardia Leads	P150012/S177	PMA supplement
2026-01-09	Kardium, Inc.	Globe® Catheter; Globe® Pulsed Field System	P240044/S004	PMA supplement
2026-01-08	Imricor Medical Systems, Inc.	Vision-MR™ Diagnostic Catheter	K252794	510(k)
2026-01-08	Boston Scientific Corp	Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, tronqué dans le dossier de la FDA	N970003/S301	PMA supplement
2026-01-08	Boston Scientific Corp	NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode tronqué dans le dossier de la FDA	P010012/S592	PMA supplement
2026-01-08	Guidant Corp.	Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 tronqué dans le dossier de la FDA	P030005/S247	PMA supplement
2026-01-08	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead 3830	P030036/S155	PMA supplement
2026-01-08	ABBOTT MEDICAL	FlexAbility™ Ablation Catheter (Flex) and FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE)	P110016/S091	PMA supplement
2026-01-08	Boston Scientific Corporation	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219	P110042/S204	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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