COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S082 · decided 2015-12-03
Approval details
- PMA number
- P000025
- Supplement
- S082
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2015-09-04
- Decision date
- 2015-12-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR A CHANGE TO THE MAGNET MATERIAL USED TO MANUFACTURETHE MI1200 SYNCHRONY MAGNET ASSEMBLIES AND THE MI1200 REPLACEMENT MAGNETS. THE CHANGE IS INTENDED TO REPLACE THE CURRENTLY USED MAGNET MATERIAL WHICH IS DISCONTINUED BY THESUPPLIER.
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