MED-EL Cochlear Implant System
FDA premarket approval P000025/S118 · decided 2020-09-04
Approval details
- PMA number
- P000025
- Supplement
- S118
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MED-EL Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2020-08-06
- Decision date
- 2020-09-04
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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