COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S094 · decided 2018-03-07
Approval details
- PMA number
- P000025
- Supplement
- S094
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2017-03-16
- Decision date
- 2018-03-07
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval order should be issued for the reinforced electrode variant +FLEXSOFT and the Insertion Electrode (IE) variant FLEXSOFT.
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