COMBI 40+ COCHLEAR SYSTEM (MAESTRO COCHLER IMPLANT SYSTEM)
FDA premarket approval P000025/S049 · decided 2010-09-17
Approval details
- PMA number
- P000025
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMBI 40+ COCHLEAR SYSTEM (MAESTRO COCHLER IMPLANT SYSTEM)
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2010-07-06
- Decision date
- 2010-09-17
- Days to decision
- 73 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- IMPLEMENTATION OF A QUALITY ASSURANCE INSPECTION STEP FOR THE INCOMING INSPECTION OF THE LIQUID SILICONE RUBBER.
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