PMA P000025S094
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S094
- Product code
- MCM
- Decision date
- 2018-03-07
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval order should be issued for the reinforced electrode variant +FLEXSOFT and the Insertion Electrode (IE) variant FLEXSOFT.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S094
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-03-07
- Decision code
- APPR
- Date received
- 2017-03-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval order should be issued for the reinforced electrode variant +FLEXSOFT and the Insertion Electrode (IE) variant FLEXSOFT.