MED-EL Cochlear Implant System
FDA premarket approval P000025/S122 · decided 2021-09-03
Approval details
- PMA number
- P000025
- Supplement
- S122
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED-EL Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2021-05-14
- Decision date
- 2021-09-03
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for a new sterilization site located at Exlgasse 20, Innsbruck, 6020, Austria for sterilization of cochlear implants and surgical accessories
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