Magnet M-01
Magnet M-01 is an active implantable device control magnet (FDA Class III; FDA product code PFN, Implanted brain stimulator for epilepsy) made by Neuropace, Inc., approved under FDA PMA P100026 on 14 Nov 2013 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00855547005137), active as of 22 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 | Number00855547005137 | Date24 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP100026 | Date14 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 00855547005137
- FDA PMA database P100026
Across registries
- FDA PMA P100026 decided 14 Nov 2013 Active
- FDA GUDID UDI-DI 00855547005137 listed 24 Sep 2014 Listed
Timeline
- Approved FDA PMA P100026
- Listed FDA GUDID 00855547005137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Magnet
- Generic name
- Active implantable device control magnet
- Model / reference
- M-01
- Primary DI / UDI-DI
- 00855547005137
- PMA number
- FDA product code
- PFN
- GMDN term
- Active implantable device control magnet
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe