|
Device | Nucleus Hybrid 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 | S035 |
Date Received | 08/13/2018 |
Decision Date | 09/10/2018 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement New internal electrode supplier for the rechargeable battery assemblies. |