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 |
|---|---|---|---|---|
| 2026-06-24 | Medtronic, Inc. | Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability tronqué dans le dossier de la FDA | P080006/S193 | PMA supplement |
| 2026-06-24 | Medtronic Cardiac Rhythm Disease Management | CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) | P830061/S236 | PMA supplement |
| 2026-06-24 | Medtronic, Inc. | Sprint Quattro Lead (6946M) | P920015/S306 | PMA supplement |
| 2026-06-24 | Medtronic, Inc. | CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B) | P930039/S278 | PMA supplement |
| 2026-06-24 | 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/S147 | PMA supplement |
| 2026-06-23 | Kardium, Inc. | Globe® Catheter and Globe® Pulsed Field System | P240044/S001 | PMA supplement |
| 2026-06-22 | ABBOTT MEDICAL | VOLT™ PFA CATHETER, SENSOR ENABLED™ | P250022/S007 | PMA supplement |
| 2026-06-18 | Zywie, Inc. | ZywieZ3 Sensor & Adhesive | K252839 | 510(k) |
| 2026-06-17 | ABBOTT MEDICAL | AVEIR Patient Transmitter LSRM01 | P150035/S040 | PMA supplement |
| 2026-06-12 | Kardium, Inc. | Globe® Catheter; Globe® Pulsed Field System | P240044/S005 | PMA supplement |
| 2026-06-11 | ABBOTT MEDICAL | The AVEIR Leadless Pacemaker (LP) | P150035/S039 | PMA supplement |
| 2026-06-11 | ABBOTT MEDICAL | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten tronqué dans le dossier de la FDA | P960013/S133 | PMA supplement |
| 2026-06-11 | ABBOTT MEDICAL | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten tronqué dans le dossier de la FDA | P960030/S084 | PMA supplement |
| 2026-06-10 | Biosense Webster, Inc. | THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS | P030031/S144 | PMA supplement |
| 2026-06-09 | Boston Scientific Corp | ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L | P010012/S611 | PMA supplement |
| 2026-06-09 | Boston Scientific | LD INGEVITY™ PLUS AF | P150012/S188 | PMA supplement |
| 2026-06-09 | Boston Scientific | RELIANCE™ S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual tronqué dans le dossier de la FDA | P910073/S192 | PMA supplement |
| 2026-06-05 | ABBOTT MEDICAL | FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM | P110016/S094 | PMA supplement |
| 2026-06-05 | St Jude Medical | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | P130026/S100 | PMA supplement |
| 2026-06-05 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ | P220013/S031 | PMA supplement |
| 2026-06-05 | Farapulse, Inc. | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, tronqué dans le dossier de la FDA | P230030/S021 | PMA supplement |
| 2026-06-04 | Medtronic, Inc. | Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS tronqué dans le dossier de la FDA | P150033/S224 | PMA supplement |
| 2026-06-03 | Boston Scientific Corp | ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE | N970003/S308 | PMA supplement |
| 2026-06-03 | Boston Scientific Corp | MOMENTUM, MOMENTUM X4, INOGEN, DYNAGEN, VIGILANT, VIGILANT X4, RESONATE, RESONATE X4, RESONATE HF | P010012/S609 | PMA supplement |
| 2026-06-03 | Boston Scientific Corp | EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467 tronqué dans le dossier de la FDA | P010012/S610 | PMA supplement |
| 2026-06-03 | Guidant Corp. | VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 | P030005/S254 | PMA supplement |
| 2026-06-03 | Boston Scientific Corporation | EMBLEM, EMBLEM MRI | P110042/S212 | PMA supplement |
| 2026-06-03 | Boston Scientific Corporation | S-ICD Electrode Model: 3501 | P110042/S213 | PMA supplement |
| 2026-06-03 | Boston Scientific | ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI | P150012/S185 | PMA supplement |
| 2026-06-03 | Boston Scientific | Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832 tronqué dans le dossier de la FDA | P150012/S186 | PMA supplement |
| 2026-06-03 | Boston Scientific | Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266 tronqué dans le dossier de la FDA | P910073/S191 | PMA supplement |
| 2026-06-03 | Boston Scientific | ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480 | P960004/S116 | PMA supplement |
| 2026-06-03 | Boston Scientific | INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF | P960040/S514 | PMA supplement |
| 2026-06-01 | Boston Scientific | INGEVITYTM+ Lead Passive Models | P150012/S187 | PMA supplement |
| 2026-05-29 | St Jude Medical | TactiCath™ Ablation Catheter, Sensor Enabled™ (TactiCath™ SE) | P130026/S101 | PMA supplement |
| 2026-05-29 | ABBOTT MEDICAL | Aveir VR (LSCD111); DR Delivery Catheter (LSCD201) | P150035/S038 | PMA supplement |
| 2026-05-29 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex™ SE) | P220013/S032 | PMA supplement |
| 2026-05-29 | Boston Scientific Corporation | POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console tronqué dans le dossier de la FDA | P220032/S012 | PMA supplement |
| 2026-05-28 | Medtronic Cardiac Rhythm Disease Management | SelectSecure Lead Model 3830 | P030036/S158 | PMA supplement |
| 2026-05-28 | ABBOTT MEDICAL | TactiFlex™ Sensor Enabled™ Ablation Catheter | P220013/S022 | PMA supplement |
| 2026-05-28 | Medtronic, Inc. | Affera Ablation System | P240013/S022 | PMA supplement |
| 2026-05-28 | Biotronik, Inc. | Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie tronqué dans le dossier de la FDA | P950037/S293 | PMA supplement |
| 2026-05-22 | Genesee Biomedical, Inc. | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | K252917 | 510(k) |
| 2026-05-19 | Boston Scientific | INGEVITY™ MRI; INGEVITY™+; INGEVITY™+ Passive | P150012/S184 | PMA supplement |
| 2026-05-15 | Boston Scientific Corp | ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604) | P010012/S608 | PMA supplement |
| 2026-05-15 | Zoll Manufacturing Corporation | LifeVest® Wearable Defibrillator | P010030/S200 | PMA supplement |
| 2026-05-15 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Cobalt X tronqué dans le dossier de la FDA | P010031/S925 | PMA supplement |
| 2026-05-15 | St Jude Medical | TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- tronqué dans le dossier de la FDA | P130026/S099 | PMA supplement |
| 2026-05-15 | Boston Scientific | Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY™ Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402 tronqué dans le dossier de la FDA | P150012/S183 | PMA supplement |
| 2026-05-15 | ABBOTT MEDICAL | TactiFlex™ Ablation Catheter, Sensor Enabled™ (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF; A-TFSE-FJ; tronqué dans le dossier de la FDA | P220013/S029 | 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.
Les liens ouvrent les dossiers propres à l’organisme. Les liens sans étiquette ouvrent des pages web. Les liens marqués (JSON) ouvrent un dossier de données d’un organisme, qu’un navigateur affiche en texte brut.
Signalez un lien brisé ou une inscription qui ne correspond pas à sa source : alerts@arrhub.com. Les corrections sont publiées, avec leur date, à arrhub.com/corrections.
© 2026 ArrHub. Contenu mis à disposition sous licence.