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
2026-01-08	St Jude Medical	TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)	P130026/S097	PMA supplement
2026-01-08	Boston Scientific	Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: tronqué dans le dossier de la FDA	P150012/S169	PMA supplement
2026-01-08	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE)	P220013/S025	PMA supplement
2026-01-08	Boston Scientific	NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG tronqué dans le dossier de la FDA	P960040/S505	PMA supplement
2026-01-06	Kardium, Inc.	Globe® Pulsed Field System	P240044/S003	PMA supplement
2026-01-05	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 CRT-D D tronqué dans le dossier de la FDA	P010031/S911	PMA supplement
2026-01-05	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S063	PMA supplement
2026-01-05	Stereotaxis, Inc.	MAGiC Ablation Catheter	P240014	PMA supplement
2026-01-05	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP tronqué dans le dossier de la FDA	P980016/S944	PMA supplement
2026-01-02	Biosense Webster, Inc.	VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump	P240006/S013	PMA supplement
2025-12-19	ABBOTT MEDICAL	Volt™ PFA System	P250022	PMA supplement
2025-12-11	Medicalgorithmics S.A.	DeepRhythmAI	K253141	510(k)
2025-12-08	Heartbeam, Inc.	HeartBeam AIMIGo with 12-L ECG Synthesis Software System	K250258	510(k)
2025-12-05	Huinno Co., Ltd.	MEMO Patch M (MPT-E08R-UNC01)	K243438	510(k)
2025-12-04	Vektor Medical, Inc.	Vektor Computational ECG Mapping System (vMap®)	K252429	510(k)
2025-11-26	Surgical Instrument Service and Savings, Inc.	Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter	K252405	510(k)
2025-08-27	Kardium, Inc.	Globe® Pulsed Field System	P240044	PMA supplement
2025-04-30	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	PMA supplement
2025-04-22	Medtronic, Inc.	OmniaSecure™ MRI SureScan™ Lead Model 3930M	P240036	PMA supplement
2025-04-11	EBR Systems, Inc.	WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System	P240028	PMA supplement
2024-11-06	Biosense Webster, Inc.	VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)	P240006	PMA supplement
2024-10-24	Medtronic, Inc.	Sphere-9 Catheter and Affera Ablation System	P240013	PMA supplement
2024-01-30	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, tronqué dans le dossier de la FDA	P230030	PMA supplement
2023-12-13	Medtronic, Inc.	PulseSelect™ Pulsed Field Ablation (PFA) system	P230017	PMA supplement
2023-10-20	Medtronic, Inc.	Aurora EV-ICD System	P220012	PMA supplement
2023-08-08	Boston Scientific Corporation	POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories	P220032	PMA supplement
2023-05-18	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C tronqué dans le dossier de la FDA	P220013	PMA supplement
2023-05-17	MicroPort CRM USA, Inc.	VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)	P130010	PMA supplement
2022-11-23	Biosense Webster, Inc.	QDOT MICRO™ System	P210027	PMA supplement
2022-03-31	ABBOTT MEDICAL	Aveir VR Leadless System	P150035	PMA supplement
2021-07-27	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	P200037	PMA supplement
2021-04-28	AtriCure, Inc.	EPi-Sense Guided Coagulation System	P200002	PMA supplement
2017-01-31	ABBOTT MEDICAL	Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software	P140033	PMA supplement
2016-04-25	Boston Scientific	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	P150012	PMA supplement
2016-04-06	Medtronic, Inc.	MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM	P150033	PMA supplement
2015-04-27	Medtronic, Inc.	MODEL 5071 LEAD	P120017	PMA supplement
2014-10-24	St Jude Medical	TACTICATH QUARTZ SET	P130026	PMA supplement
2012-09-28	Boston Scientific Corporation	SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM	P110042	PMA supplement
2012-01-25	ABBOTT MEDICAL	THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR	P110016	PMA supplement
2011-12-14	AtriCure, Inc.	ATRICURE SYNERGY ABLATION SYSTEM	P100046	PMA supplement
2010-12-17	Medtronic Cryocath, LP	ARCTIC FRONT CRYOCATHETER SYSTEM	P100010	PMA supplement
2009-04-07	Medtronic, Inc.	MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD	P080006	PMA supplement
2008-06-13	Medtronic, Inc.	ATTAIN STARFIX MODEL 4195 LEAD	P060039	PMA supplement
2008-05-12	Biotronik, Inc.	STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD	P070008	PMA supplement
2007-03-16	Irvine Biomedical, Inc.	IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF	P060019	PMA supplement
2006-08-10	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD	P050023	PMA supplement
2005-11-18	Irvine Biomedical,Inc.(Ibi)	THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER	P040042	PMA supplement
2005-08-03	Medtronic Cardiac Rhythm Disease Management	MEDTRONIC SELECTSECURE LEAD MODEL 3830	P030036	PMA supplement
2005-01-14	Irvine Biomedical, Inc.	IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR	P040014	PMA supplement
2004-11-05	Biosense Webster, Inc.	BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS	P030031	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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