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Device | NUCLEUS HYBRID L24 IMPLANT SYSTEM |
Generic Name | Cochlear implant with combined electrical stimulation and acoustic amplification |
Applicant | Cochlear Americas 10350 Park Meadows Drive Centennial, CO 80124 |
PMA Number | P130016 |
Supplement Number | S021 |
Date Received | 10/06/2016 |
Decision Date | 09/22/2017 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |