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Device | MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM |
Generic Name | Cochlear implant with combined electrical stimulation and acoustic amplification |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S092 |
Date Received | 10/13/2016 |
Decision Date | 12/08/2016 |
Product Code |
PGQ |
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 protocol for the post-approval study. |