M-50 112149
M-50 112149 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 16 Oct 2024 (UDI-DI 04035479001575), 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 | Number04035479001575 | Date16 Oct 2024 | StatusListed |
| United States | FDA PMAAPPR | NumberP950037 | Date11 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 04035479001575
- FDA PMA database P950037
Across registries
- FDA PMA P950037 decided 11 Oct 1996 Active
- FDA GUDID UDI-DI 04035479001575 listed 16 Oct 2024 Listed
Timeline
- Approved FDA PMA P950037
- Listed FDA GUDID 04035479001575
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- M-50
- Generic name
- Cardiac pulse generator test magnet
- Model / Ref / Catalog
- 112149
- Primary DI / UDI-DI
- 04035479001575
- FDA product code
- KRG
- GMDN term
- Cardiac pulse generator test magnet
- Device class
- Class III
- Regulation number
- 870.3700
- GUDID distribution status
- In Commercial Distribution
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