COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR
FDA premarket approval P000025/S029 · decided 2008-04-08
Approval details
- PMA number
- P000025
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2007-10-25
- Decision date
- 2008-04-08
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE OPUS 2 SPEECH PROCESSOR AS AN ADDITIONAL EXTERNAL BEHIND-THE-EAR SPEECH PROCESSOR FOR USE WITH THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
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