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
2026-05-15	Medtronic, Inc.	Sphere-9 Catheter and Affera Ablation System	P240013/S025	PMA supplement
2026-05-15	Boston Scientific	Vein Pick (Model 6541)	P830060/S093	PMA supplement
2026-05-15	Boston Scientific	ACUITY™ X4 Connector Tool (Model 4625); RELIANCE™ 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit tronqué dans le dossier de la FDA	P910073/S190	PMA supplement
2026-05-15	Boston Scientific	DF-1 Plug (Model 6996)	P910077/S199	PMA supplement
2026-05-15	Boston Scientific	Hex Wrench (#2) (Model 6501)	P930035/S037	PMA supplement
2026-05-15	Biotronik, Inc.	Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes	P950037/S292	PMA supplement
2026-05-15	Boston Scientific	Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606 tronqué dans le dossier de la FDA	P960004/S115	PMA supplement
2026-05-15	Boston Scientific	Fixation Tool (Model 6616)	P960006/S059	PMA supplement
2026-05-15	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/S958	PMA supplement
2026-05-14	Medtronic, Inc.	Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar tronqué dans le dossier de la FDA	P010015/S583	PMA supplement
2026-05-13	Medtronic, Inc.	Sphere-9™ Mapping and Ablation Catheter; Tubing Set; Extension Cable	P240013/S027	PMA supplement
2026-05-08	Medtronic, Inc.	Micra Cathode Press Station 2	P150033/S227	PMA supplement
2026-05-07	Biotronik, Inc.	Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T	P000009/S129	PMA supplement
2026-05-07	Biotronik, Inc.	Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, tronqué dans le dossier de la FDA	P050023/S210	PMA supplement
2026-05-07	Biotronik, Inc.	Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Amvia Sky HF-T, Amvia Sky tronqué dans le dossier de la FDA	P070008/S178	PMA supplement
2026-05-07	Biotronik, Inc.	Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 SR-T, Evity 8 S tronqué dans le dossier de la FDA	P950037/S290	PMA supplement
2026-05-07	Biotronik, Inc.	Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva tronqué dans le dossier de la FDA	P980023/S145	PMA supplement
2026-05-06	AtriCure, Inc.	Synergy Ablation System	P100046/S020	PMA supplement
2026-05-06	AtriCure, Inc.	EPi-Sense and EPi-Sense ST Guided Coagulation System	P200002/S014	PMA supplement
2026-05-06	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System	P230030/S019	PMA supplement
2026-05-01	Biotronik, Inc.	BIOMONITOR IV (471155)	K261074	510(k)
2026-04-30	Medtronic, Inc.	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar tronqué dans le dossier de la FDA	P010015/S581	PMA supplement
2026-04-30	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M tronqué dans le dossier de la FDA	P010031/S918	PMA supplement
2026-04-30	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/S924	PMA supplement
2026-04-30	Medtronic, Inc.	Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)	P150033/S223	PMA supplement
2026-04-30	Medtronic, Inc.	Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra VR2 TPS	P150033/S226	PMA supplement
2026-04-30	Medtronic, Inc.	Aurora EV-ICD	P220012/S072	PMA supplement
2026-04-30	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC tronqué dans le dossier de la FDA	P980016/S951	PMA supplement
2026-04-30	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/S957	PMA supplement
2026-04-28	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/S923	PMA supplement
2026-04-28	Medtronic, Inc.	Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD	P220012/S071	PMA supplement
2026-04-28	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/S956	PMA supplement
2026-04-24	Biotronik, Inc.	Renamic Neo	P000009/S127	PMA supplement
2026-04-24	ABBOTT MEDICAL	Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps	P030035/S212	PMA supplement
2026-04-24	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/S442	PMA supplement
2026-04-24	ABBOTT MEDICAL	Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q tronqué dans le dossier de la FDA	P030054/S444	PMA supplement
2026-04-24	Biotronik, Inc.	Renamic Neo	P050023/S207	PMA supplement
2026-04-24	Biotronik, Inc.	Renamic Neo	P070008/S175	PMA supplement
2026-04-24	ABBOTT MEDICAL	Assurity MRI, Endurity MRI family of Pacemakers	P140033/S102	PMA supplement
2026-04-24	ABBOTT MEDICAL	Aveir Leadless System	P150035/S037	PMA supplement
2026-04-24	Medtronic, Inc.	OmniaSecure™ MRI SureScan™ Lead Model 3930M	P240036/S005	PMA supplement
2026-04-24	Medtronic, Inc.	OmniaSecure™ MRI SureScan™ Lead Model 3930M	P240036/S006	PMA supplement
2026-04-24	ABBOTT MEDICAL	Assurity, Assurity+, Endurity, Accent family of Pacemakers	P880086/S346	PMA supplement
2026-04-24	ABBOTT MEDICAL	Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs	P910023/S484	PMA supplement
2026-04-24	ABBOTT MEDICAL	Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q)	P950022/S152	PMA supplement
2026-04-24	Biotronik, Inc.	Renamic Neo	P950037/S285	PMA supplement
2026-04-23	Cortex, Inc.	OptiMap Catheter - 60mm (OPTI-CATH2-60)	K261012	510(k)
2026-04-23	Medtronic, Inc.	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C tronqué dans le dossier de la FDA	P010015/S585	PMA supplement
2026-04-23	Medtronic Cryocath, LP	Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5	P020045/S113	PMA supplement
2026-04-23	Medtronic Cryocath, LP	Freezor MAX 209F3,209F5	P100010/S153	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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