PMA P000025S113
- Device
- COMBI 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S113
- Product code
- MCM
- Decision date
- 2019-10-15
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval of the Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study protocol.
Current openFDA PMA Record#
- Device
- COMBI 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S113
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2019-10-15
- Decision code
- APPR
- Date received
- 2019-08-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study protocol.