PMA P000025S105
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S105
- Product code
- MCM
- Decision date
- 2018-09-19
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Change in the manufacturing of the cochlear implants SONATA, Mi1000 MED-EL CONCERT, and Mi1200 SYNCHRONY.
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S105
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-09-19
- Decision code
- OK30
- Date received
- 2018-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the manufacturing of the cochlear implants SONATA, Mi1000 MED-EL CONCERT, and Mi1200 SYNCHRONY.