|
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 | S028 |
Date Received | 05/23/2017 |
Decision Date | 11/17/2017 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval order for the remote programing of Nucleus Hybrid L24 Implant System using telehealth technology should be issued. |