Nucleus Cochlear Implant System
FDA premarket approval P970051/S161 · decided 2017-07-17
Approval details
- PMA number
- P970051
- Supplement
- S161
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2017-04-18
- Decision date
- 2017-07-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the CP802 Sound Processor.
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