MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S037 · decided 2008-10-09
Approval details
- PMA number
- P000025
- Supplement
- S037
- Supplement type
- Special (Immediate Track)
- 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
- 2008-09-12
- Decision date
- 2008-10-09
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR ADDING INSPECTIONS FOR SHORT CIRCUITS IN THE MANUFACTURING OF THE SONATA AND PULSAR IMPLANTS.
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