Dh 331668
Dh 331668 is a Class III device made by BIOTRONIK SE & Co. KG, approved under FDA PMA P950037 on 11 Oct 1996 and listed in FDA GUDID since 14 Aug 2014 (UDI-DI 04035479144807), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04035479144807 | Date14 Aug 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP950037 | Date11 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 04035479144807
- FDA PMA database P950037
Across registries
- FDA PMA P950037 decided 11 Oct 1996 Active
- FDA GUDID UDI-DI 04035479144807 listed 14 Aug 2014 Listed
Timeline
- Approved FDA PMA P950037
- Listed FDA GUDID 04035479144807
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Dh
- Generic name
- Endocardial/interventricular septal pacing lead
- Model / Ref / Catalog
- 331668
- Primary DI / UDI-DI
- 04035479144807
- FDA product code
- NVN
- GMDN term
- Endocardial/interventricular septal pacing lead
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
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