MED-EL COCHLEAR IMPLANT SYSTEMS
FDA premarket approval P000025/S059 · decided 2011-12-16
Approval details
- PMA number
- P000025
- Supplement
- S059
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COCHLEAR IMPLANT SYSTEMS
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2011-10-17
- Decision date
- 2011-12-16
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE OPUS 2 BATTERY PACK XS WHICH IS AN ADDITIONAL OPTIONAL BATTERY PACK FOR USE WITH THE FOLLOWING APPROVED AUDIO PROCESSORS OF THE MED-EL COCHLEAR IMPLANT (CI) SYSTEM: TEMPO+, OPUS 1 AND OPUS 2.
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