Neuro Cochlear Implant System 157975
by Neurelec
Neuro Cochlear Implant System 157975 is a Class III device made by Neurelec, approved under FDA PMA P200021 on 23 Jun 2021 and listed in FDA GUDID since 6 Oct 2021 (UDI-DI 03663227001471), withdrawn as of 23 Oct 2026.
Withdrawn
PMA, withdrawn
Ended
Withdrawn 23 Jun 2021
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03663227001471 | Date6 Oct 2021 | StatusListed |
| United States | FDA PMAAPWD | NumberP200021 | Date23 Jun 2021 | StatusWithdrawn |
Official records
- AccessGUDID record 03663227001471
- FDA PMA database P200021
Across registries
- FDA PMA P200021 decided 23 Jun 2021 Withdrawn
- FDA GUDID UDI-DI 03663227001471 listed 6 Oct 2021 Listed
Timeline
- Approved FDA PMA P200021
- Listed FDA GUDID 03663227001471
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Withdrawn
Specification
- Trade name
- Neuro Cochlear Implant System
- Generic name
- Cochlear implant/auditory brainstem implant sound processor
- Model / reference
- 157975
- Primary DI / UDI-DI
- 03663227001471
- PMA number
- FDA product code
- MCM
- GMDN term
- Cochlear implant/auditory brainstem implant sound processor
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Cochlear implant/auditory brainstem implant sound processor.