Bk-IS4/DF4 395399
Bk-IS4/DF4 395399 is a Class III device made by BIOTRONIK SE & Co. KG, approved under FDA PMA P980023 on 27 Oct 1998 and listed in FDA GUDID since 20 Aug 2014 (UDI-DI 04035479132613), 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 | Number04035479132613 | Date20 Aug 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP980023 | Date27 Oct 1998 | StatusActive |
Official records
- AccessGUDID record 04035479132613
- FDA PMA database P980023
Across registries
- FDA PMA P980023 decided 27 Oct 1998 Active
- FDA GUDID UDI-DI 04035479132613 listed 20 Aug 2014 Listed
Timeline
- Approved FDA PMA P980023
- Listed FDA GUDID 04035479132613
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Bk-IS4/DF4
- Generic name
- Pacing/defibrillation lead cap
- Model / Ref / Catalog
- 395399
- Primary DI / UDI-DI
- 04035479132613
- PMA number
- FDA product code
- NVY
- GMDN term
- Pacing/defibrillation lead cap
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution