MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S011 · decided 2003-07-22
Approval details
- PMA number
- P000025
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2003-06-18
- Decision date
- 2003-07-22
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR VERTICAL INTEGRATION OF THE COCHLEAR IMPLANT LASER WELDING PROCESS AT THE MANUFACTURING SITE LOCATED AT MED-EL MEDICAL ELECTRONICS, INNSBRUCK, AUSTRIA.
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