FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Cochlear
PMA: P970051
·
Supplement: S116
·
Decision Jan 22, 2015
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- NUCLEUS CI512 COCHLEAR IMPLANT
- PMA Number
- P970051
- Supplement Number
- S116
- 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
- January 22, 2015
- Date Received
- January 27, 2014
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at Cochlear Limited - Macquarie, 1 University Avenue, Macquarie University, NSW 2109, Australia.
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 |