Nucleus Cochlear Implant System
FDA premarket approval P970051/S203 · decided 2021-04-21
Approval details
- PMA number
- P970051
- Supplement
- S203
- 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
- 2021-01-19
- Decision date
- 2021-04-21
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the Model CP1001 and CP1002 Sound Processors, which are additions to the CP1000 series of Sound Processors.
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