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
2004-06-30	ABBOTT MEDICAL	ST JUDE MEDICAL EPIC HF SYSTEM	P030054	PMA supplement
2004-05-13	ABBOTT MEDICAL	ANTHEM AND FRONTIER II CRT-P'S	P030035	PMA supplement
2004-01-26	Guidant Corp.	CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE	P030005	PMA supplement
2003-04-17	Medtronic Cryocath, LP	7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM	P020045	PMA supplement
2002-06-26	Medtronic Cardiac Rhythm Disease Management	CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION	P010031	PMA supplement
2002-05-02	Boston Scientific Corp	CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL tronqué dans le dossier de la FDA	P010012	PMA supplement
2001-12-18	Zoll Manufacturing Corporation	WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST	P010030	PMA supplement
2001-08-28	Medtronic, Inc.	MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM	P010015	PMA supplement
2000-09-29	Biotronik, Inc.	PHYLAX AV ICD SYSTEM	P000009	PMA supplement
2000-06-14	Medtronic, Inc.	MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF tronqué dans le dossier de la FDA	P980050	PMA supplement
1999-06-03	Boston Scientific Corp	PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE	N970003	PMA supplement
1999-05-04	St Jude Medical	LIVEWIRE(R) CARDIAC ABLATION SYSTEM	P960016	PMA supplement
1998-10-27	Biotronik, Inc.	PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	P980023	PMA supplement
1998-10-09	Medtronic Cardiac Rhythm Disease Management	VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS	P980016	PMA supplement
1998-10-02	Boston Scientific	SWEET TIP(R) RX STEROID ELUTING LEAD	P960006	PMA supplement
1998-01-29	ABBOTT MEDICAL	PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS	P960030	PMA supplement
1997-07-18	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	PMA supplement
1997-06-20	ABBOTT MEDICAL	TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS	P960013	PMA supplement
1996-11-12	Boston Scientific	THINLINE ENDOCARDIAL PACING LEADS	P960004	PMA supplement
1996-10-11	Biotronik, Inc.	DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS	P950037	PMA supplement
1996-09-06	Medtronic, Inc.	MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695	P950024	PMA supplement
1996-05-10	ABBOTT MEDICAL	TVL(TM) LEAD SYSTEM	P950022	PMA supplement
1996-03-29	Medtronic, Inc.	MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568	P930039	PMA supplement
1995-03-10	Boston Scientific	VENTAK(R) P2 SYSTEM	P930035	PMA supplement
1994-06-17	Boston Scientific	VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR	P910077	PMA supplement
1993-12-09	Medtronic, Inc.	MEDTRONIC(R) TRANSVENE LEAD SYSTEM	P920015	PMA supplement
1993-08-26	Boston Scientific	ENDOTAK LEAD SYSTEM	P910073	PMA supplement
1993-04-30	ABBOTT MEDICAL	CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM	P910023	PMA supplement
1993-02-11	Medtronic Cardiac Rhythm Disease Management	MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM	P900061	PMA supplement
1989-08-21	ABBOTT MEDICAL	ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS	P880086	PMA supplement
1986-07-29	Medtronic Cardiac Rhythm Disease Management	STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING	P830061	PMA supplement
1986-07-29	Medtronic Cardiac Rhythm Disease Management	CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS	P850089	PMA supplement
1985-10-04	Boston Scientific	VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS	P830060	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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