|
Device | COMBI 40+ Cochlear Implant System |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S113 |
Date Received | 08/16/2019 |
Decision Date | 10/15/2019 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study protocol. |