PMA P000025
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S123
- Product code
- MCM
- Decision date
- 2026-10-09
- Generic name
- Implant, cochlear
- Approval order statement
- approval for expanding the shelf-life of a raw material used for making the overmold of the MED-EL cochlear implants
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S136
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2026-10-09
- Decision code
- APPR
- Date received
- 2025-06-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for expanding the shelf-life of a raw material used for making the overmold of the MED-EL cochlear implants