PMA P000025S118
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S118
- Product code
- MCM
- Decision date
- 2020-09-04
- Generic name
- Implant, cochlear
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S118
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-09-04
- Decision code
- APPR
- Date received
- 2020-08-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.