Explant Kit EX-01-K
Explant Kit EX-01-K is a brain-responsive electrical stimulation system (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 22 Feb 2022 (UDI-DI 00855547005410), 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 | Number00855547005410 | Date22 Feb 2022 | StatusListed |
| United States | FDA PMAAPPR | NumberP100026 | Date14 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 00855547005410
- FDA PMA database P100026
Across registries
- FDA PMA P100026 decided 14 Nov 2013 Active
- FDA GUDID UDI-DI 00855547005410 listed 22 Feb 2022 Listed
Timeline
- Approved FDA PMA P100026
- Listed FDA GUDID 00855547005410
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Explant Kit
- Generic name
- Brain-responsive electrical stimulation system
- Model / reference
- EX-01-K
- Primary DI / UDI-DI
- 00855547005410
- PMA number
- FDA product code
- PFN
- GMDN term
- Brain-responsive electrical stimulation system
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional