MED-EL Cochlear Implant System
FDA premarket approval P000025/S102 · decided 2018-08-10
Approval details
- PMA number
- P000025
- Supplement
- S102
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED-EL Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2018-07-12
- Decision date
- 2018-08-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Facility change in the manufacturing of cochlear implants SONATA, Mi1000 MED-EL Concert, Mi1200 Synchrony, and of the single use surgical instruments Insertion Test Device (ITD) and Insertion Electrodes (IE).
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