COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S052 · decided 2011-07-22
Approval details
- PMA number
- P000025
- Supplement
- S052
- 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
- 2011-05-23
- Decision date
- 2011-07-22
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR INTRODUCTION OF THE MINI BATTERY PACK, AN OPTIONAL EXTERNAL BATTERY PACK TO BE USED TO POWER THE TEMPO+, OPUS 1, AND OPUS2 AUDIO PROCESSORS.
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