MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S046 · decided 2010-09-03
Approval details
- PMA number
- P000025
- Supplement
- S046
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2010-03-18
- Decision date
- 2010-09-03
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR A CHANGE IN MED-EL¿S SUPPLIER OF A CRITICAL COMPONENT WITH DIRECT IMPACT ON THE SAFETY AND EFFICACY OF THE SONATA IMPLANTS.
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