Sorin CRM SAS
CLAMART Hauts-de-Seine, FR
Sorin CRM SAS appears in FDA device records in CLAMART Hauts-de-Seine, FR. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008159616 | 3008159616 | Sorin CRM SAS | 4, avenue Reaumur, CLAMART Hauts-de-Seine 92140 FR | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DQKComputer, Diagnostic, Programmable
- NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- MRMDefibrillator, Implantable, Dual-Chamber
- NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- LWSImplantable Cardioverter Defibrillator (Non-Crt)
- DXYImplantable Pacemaker Pulse-Generator
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)
- DTGMagnet, Test, Pacemaker
- OSRPacemaker/Icd/Crt Non-Implanted Components
- NVZPulse Generator, Permanent, Implantable
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2825-2018 | Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator | Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy. | Class II | Terminated | |
| Z-2824-2018 | Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator | Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain