MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S068 · decided 2013-05-16
Approval details
- PMA number
- P000025
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2013-03-01
- Decision date
- 2013-05-16
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE REUSABLE MI1000 PIN DRILL GUIDE WHICH ASSISTS IN THE SURGICAL IMPLANTATION OF THE APPROVED MI1000 CONCERT PIN IMPLANT.
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