FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Cochlear
PMA: P970051
·
Supplement: S237
·
Decision Sep 2, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P970051 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- Cochlear Nucleus® System
- PMA Number
- P970051
- Supplement Number
- S237
- Device Class
- FDA Class 3
- Product Code
- MCM
- Generic Name
- Implant, cochlear
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 2, 2025
- Date Received
- August 1, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
This revision includes data from an IDE study (G190269) to complete the pediatric recruitment arm of this PAS. These additional data are from 23 subjects whose audiometric inclusion criteria overlap with the inclusion criteria for this PAS.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCM | Implant, Cochlear | FDA class 3 | Unknown |