PMA P000025S122
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S122
- Product code
- MCM
- Decision date
- 2021-09-03
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for a new sterilization site located at Exlgasse 20, Innsbruck, 6020, Austria for sterilization of cochlear implants and surgical accessories
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S122
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-09-03
- Decision code
- APPR
- Date received
- 2021-05-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new sterilization site located at Exlgasse 20, Innsbruck, 6020, Austria for sterilization of cochlear implants and surgical accessories