MED EL C40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S031 · decided 2008-04-18
Approval details
- PMA number
- P000025
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED EL C40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2008-01-23
- Decision date
- 2008-04-18
- Days to decision
- 86 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- MODIFICATIONS AS FOLLOWS: 1) ADAPTION OF ENCLOSED TESTS AT HEADER INCOMING INSPECTION; 2) CHANGE IN INCOMING INSPECTION PROCEDURE FOR CABLES OF REMOTE BATTERY PACK; 3) INTRODUCTION OF SILICONE MIXING MACHINE; 4)CHANGE IN MANUFACTURING PROCEDURE FOR WELDING OF COIL; 5) ALTERNATIVE EQUIPMENT TO MEASURE STRENGTH OF MAGNETS; 6) CHANGES TO ELECTRODE MOULDS; 7) CHANGE IN SPRINT; AND 8) NEW MOULD SHAPE.
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