Neuro Cochlear Implant System
FDA premarket approval P200021/S001 · decided 2021-08-20
Approval details
- PMA number
- P200021
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Neuro Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Oticon Medical
- Date received
- 2021-07-23
- Decision date
- 2021-08-20
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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