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Device | Nucleus Hybrid Cochlear 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 | S025 |
Date Received | 04/10/2017 |
Decision Date | 05/09/2017 |
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 Transfer of the Arburg 220S Molding Machine (CP800/CP900 Injection Molding Tool System) from the Lane Cove manufacturing site to the Macquarie manufacturing site. |