Data / Medical devices / France / Sorin CRM SAS
Sorin CRM SAS: FDA-registered device maker in CLAMART Hauts-de-Seine, France, 2 510(k) clearances and 4 PMA approvals
Sorin CRM SAS is registered with the FDA (registration 3008159616) in CLAMART Hauts-de-Seine, France. It lists 11 device types. The FDA files 2 510(k) clearances and 4 PMA approvals under its listings, the newest dated May 17, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008159616
- Address
- 4, avenue Reaumur, CLAMART Hauts-de-Seine, France, 92140
- Owner or operator
- MicroPort CRM USA, Inc. (2182863)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- January 6, 2011
- Registered through
- 2026
- Brand names listed
- ALIZEA DR 1600, ALIZEA SR 1300, Accessory for pacemaker, ICD and CRT-D Permanent magnet, Accessory for pacemaker, ICD and CRT-D Screw driver, CELEA DR 1400, CELEA SR 1100, CPR3 telemetry wand (Accessory to SmartView Hotspot), CPR4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Defibrillator, Implantable, Dual-Chamber | MRM | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implantable Pacemaker Pulse-Generator | DXY | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Magnet, Test, Pacemaker | DTG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pulse Generator, Permanent, Implantable | NVZ | 3 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 20, 2004 | K042002 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER | DQK | Substantially Equivalent | Ela Medical, Inc. | accessdata.fda.gov |
| August 22, 2003 | K032466 | SPIDERVIEW | MWJ | Substantially Equivalent | Ela Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 17, 2023 | P130010 | VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) | NVN | 5 | January 15, 2026 | accessdata.fda.gov |
| May 15, 2008 | P060027 | OVATIO CRT SYSTEM | NIK | 104 | November 25, 2025 | accessdata.fda.gov |
| September 15, 1999 | P980049 | DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | MRM | 145 | November 25, 2025 | accessdata.fda.gov |
| March 10, 1997 | P950029 | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER | DXY | 128 | July 23, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 9, 2018 | 80636 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Pulse Generator, Permanent, Implantable
- All makers of Implantable Pulse Generator, Pacemaker (Non-Crt)
- All makers of Implantable Pacemaker Pulse-Generator
- All makers of Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
- All makers of Pacemaker/Icd/Crt Non-Implanted Components
Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.