Esprit SR
Esprit SR is a Class III device made by Microport Crm SRL, approved under FDA PMA P950029 on 10 Mar 1997 and listed in FDA GUDID since 5 Sep 2014 (UDI-DI 08031527009162), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08031527009162 | Date5 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP950029 | Date10 Mar 1997 | StatusActive |
Official records
- AccessGUDID record 08031527009162
- FDA PMA database P950029
Across registries
- FDA PMA P950029 decided 10 Mar 1997 Active
- FDA GUDID UDI-DI 08031527009162 listed 5 Sep 2014 Listed
Recalls
-
- Terminated Z-2235-2009
Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.
Timeline
- Approved FDA PMA P950029
- Recall initiated FDA recalls Z-2235-2009
- Listed FDA GUDID 08031527009162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Esprit
- Generic name
- Single-chamber implantable pacemaker, rate-responsive
- Model / reference
- SR
- Primary DI / UDI-DI
- 08031527009162
- PMA number
- FDA product code
- NVZ
- GMDN term
- Single-chamber implantable pacemaker, rate-responsive
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NVZ (Pulse generator, permanent, implantable).