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
2026-03-18	Boston Scientific	INGEVITY™+ Pace / Sense Lead – Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J tronqué dans le dossier de la FDA	P150012/S178	PMA supplement
2026-03-13	Cortex, Inc.	OptiMap Catheter - 50mm (OPTI-CATH2-50)	K253205	510(k)
2026-03-09	Medtronic, Inc.	OmniaSecure™ MRI SureScan™ Lead Model 3930M	P240036/S004	PMA supplement
2026-03-06	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/S582	PMA supplement
2026-03-06	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/S920	PMA supplement
2026-03-06	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead	P030036/S157	PMA supplement
2026-03-06	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	P200037/S018	PMA supplement
2026-03-06	Medtronic, Inc.	Aurora EV ICD; Epsila EV Extravascular Lead	P220012/S068	PMA supplement
2026-03-06	Medtronic, Inc.	Sphere-9 Catheter (AFR-00001)	P240013/S020	PMA supplement
2026-03-06	Boston Scientific	ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads	P910073/S187	PMA supplement
2026-03-06	Medtronic, Inc.	HV Splitter/ Adaptor kit	P920015/S304	PMA supplement
2026-03-06	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 I CD; Ev tronqué dans le dossier de la FDA	P980016/S953	PMA supplement
2026-03-05	Biotronik, Inc.	Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 tronqué dans le dossier de la FDA	P050023/S208	PMA supplement
2026-03-05	Biotronik, Inc.	Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 tronqué dans le dossier de la FDA	P070008/S176	PMA supplement
2026-03-05	Biotronik, Inc.	Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En tronqué dans le dossier de la FDA	P950037/S286	PMA supplement
2026-03-05	Biotronik, Inc.	Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk tronqué dans le dossier de la FDA	P980023/S144	PMA supplement
2026-03-04	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M tronqué dans le dossier de la FDA	P010031/S919	PMA supplement
2026-03-04	Element Science, Inc.	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class tronqué dans le dossier de la FDA	P230022/S003	PMA supplement
2026-03-04	Medtronic Cardiac Rhythm Disease Management	Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I tronqué dans le dossier de la FDA	P980016/S952	PMA supplement
2026-03-03	Medtronic, Inc.	HexaGen™ RF Generator	P240013/S019	PMA supplement
2026-02-23	Medtronic, Inc.	Miera AV TPS; Miera TPS	P150033/S222	PMA supplement
2026-02-23	ABBOTT MEDICAL	Aveir DR Delivery Catheter (LSCD201)	P150035/S034	PMA supplement
2026-02-20	Boston Scientific Corporation	EMBLEM S-ICD Electrode (Lead)	P110042/S203	PMA supplement
2026-02-20	Medtronic, Inc.	Myocardial Pacing Lead	P120017/S039	PMA supplement
2026-02-20	Boston Scientific	ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads	P910073/S185	PMA supplement
2026-02-19	ABBOTT MEDICAL	Quartet; QuickFlex Micro	P030054/S435	PMA supplement
2026-02-19	ABBOTT MEDICAL	Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular)	P150035/S026	PMA supplement
2026-02-19	ABBOTT MEDICAL	Durata, Optisure	P950022/S148	PMA supplement
2026-02-19	ABBOTT MEDICAL	Tendril STS; OptiSense; UltiPace	P960013/S129	PMA supplement
2026-02-19	ABBOTT MEDICAL	IsoFlex	P960030/S080	PMA supplement
2026-02-18	Kardium, Inc.	Globe Catheter (601-01000)	P240044/S002	PMA supplement
2026-02-17	Medtronic, Inc.	PulseSelect™ Pulsed Field Ablation (PFA) system	P230017/S009	PMA supplement
2026-02-13	Measure Labs, Inc. (Dba Preemptiveai, Inc.)	PreemptiveAI Clinical SDK	K250233	510(k)
2026-02-13	Boston Scientific Corp	ACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod tronqué dans le dossier de la FDA	P010012/S602	PMA supplement
2026-02-13	ABBOTT MEDICAL	Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); tronqué dans le dossier de la FDA	P030054/S441	PMA supplement
2026-02-13	Boston Scientific Corporation	EMBLEM™ S-ICD/ model 3501	P110042/S208	PMA supplement
2026-02-13	Boston Scientific	INGEVITY™ MRI/ model 7731; INGEVITY™ MRI/ model 7732; INGEVITY™ MRI/ model 7735; INGEVITY™ MRI/ model 7736; INGEVITY™ MR tronqué dans le dossier de la FDA	P150012/S179	PMA supplement
2026-02-13	ABBOTT MEDICAL	Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); tronqué dans le dossier de la FDA	P910023/S483	PMA supplement
2026-02-13	Boston Scientific	RELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC tronqué dans le dossier de la FDA	P910073/S186	PMA supplement
2026-02-13	Medtronic, Inc.	Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M)	P920015/S303	PMA supplement
2026-02-12	Medtronic, Inc.	Consulta CRT-P C4TR01 Syncra CRT-P C2TR01	P010015/S580	PMA supplement
2026-02-12	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/S916	PMA supplement
2026-02-12	Medtronic, Inc.	Aurora EV ICD DVEA3E4	P220012/S067	PMA supplement
2026-02-12	Biosense Webster, Inc.	VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)	P240006/S014	PMA supplement
2026-02-12	Biotronik, Inc.	Solia CSP S 53; Solia CSP S 60	P950037/S280	PMA supplement
2026-02-12	Medtronic Cardiac Rhythm Disease Management	Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD tronqué dans le dossier de la FDA	P980016/S949	PMA supplement
2026-02-11	Biotronik, Inc.	PHYLAX AV ICD SYSTEM	P000009/S125	PMA supplement
2026-02-11	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/S914	PMA supplement
2026-02-11	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD	P050023/S205	PMA supplement
2026-02-11	Medtronic, Inc.	Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac tronqué dans le dossier de la FDA	P150033/S221	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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