MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT
FDA premarket approval P000025/S058 · decided 2012-11-21
Approval details
- PMA number
- P000025
- Supplement
- S058
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2011-10-17
- Decision date
- 2012-11-21
- Days to decision
- 401 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT.
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