COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)
FDA premarket approval P000025/S083 · decided 2015-12-29
Approval details
- PMA number
- P000025
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2015-11-30
- Decision date
- 2015-12-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- ALTERNATIVES TO BATCH TESTING FOR BACTERIAL ENDOTOXINS AND ESTABLISHMENT OF A DYNAMIC SAMPLING PLAN.
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