Mi1210 SYNCHRONY ST Cochlear Implant
FDA premarket approval P000025/S103 · decided 2019-01-22
Approval details
- PMA number
- P000025
- Supplement
- S103
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mi1210 SYNCHRONY ST Cochlear Implant
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2018-07-18
- Decision date
- 2019-01-22
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the Mi1210 SYNCHRONY ST Cochlear Implant +Standard, +Medium, +Compressed, +FLEXSOFT, +FLEX24, +FLEX28 (for non-EAS patients), the Mi1210 SYNCHRONY ST Cochlear Implant +FLEX20, +FLEX24 (for EAS patients), the Mi1210 Implant Template, and associated surgical accessories.
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