COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S086 · decided 2016-05-11
Approval details
- PMA number
- P000025
- Supplement
- S086
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2016-02-11
- Decision date
- 2016-05-11
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the optional protection covering accessory called the WaterWear for SONNET or OPUS 2 behind-the-ear (BTE) audio processors.
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