PMA P000025S123
- Device
- MED-EL CONCERT (PIN) Cochlear Implant
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S123
- Product code
- MCM
- Decision date
- 2022-05-18
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the Mi1050 CONCERTO 2 (PIN) implant which incorporates a design change to a central lead exit of the approved Mi1000 CONCERT (PIN) implant.
Current openFDA PMA Record#
- Device
- MED-EL CONCERT (PIN) Cochlear Implant
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S123
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-05-18
- Decision code
- APPR
- Date received
- 2022-01-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Mi1050 CONCERTO 2 (PIN) implant which incorporates a design change to a central lead exit of the approved Mi1000 CONCERT (PIN) implant.