MED-EL CONCERT (PIN) Cochlear Implant
FDA premarket approval P000025/S123 · decided 2022-05-18
Approval details
- PMA number
- P000025
- Supplement
- S123
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL CONCERT (PIN) Cochlear Implant
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2022-01-26
- Decision date
- 2022-05-18
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the Mi1050 CONCERTO 2 (PIN) implant which incorporates a design change to a central lead exit of the approved Mi1000 CONCERT (PIN) implant.
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