Biotronik Scs Pp
Biotronik Scs Pp (457854) is a Class III device made by BIOTRONIK SE & Co. KG, approved under FDA PMA P210037 on 31 Mar 2023 and listed in FDA GUDID since 6 Apr 2023 (UDI-DI 04035479170318), 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 | Number04035479170318 | Date6 Apr 2023 | StatusListed |
| United States | FDA PMAAPPR | NumberP210037 | Date31 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 04035479170318
- FDA PMA database P210037
Across registries
- FDA PMA P210037 decided 31 Mar 2023 Active
- FDA GUDID UDI-DI 04035479170318 listed 6 Apr 2023 Listed
Timeline
- Approved FDA PMA P210037
- Listed FDA GUDID 04035479170318
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Biotronik
- Generic name
- Implantable pulse generator port plug
- Model / Ref / Catalog
- SCS PP, 457854
- Primary DI / UDI-DI
- 04035479170318
- PMA number
- FDA product code
- LGW
- GMDN term
- Implantable pulse generator port plug
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Implantable pulse generator port plug.