|
Device | NUCLEUS 24 HYBRID 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 | S015 |
Date Received | 01/06/2016 |
Decision Date | 02/05/2016 |
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 Introduction of a pre-bake of the electronic assembly prior to pre-tinning and soldering of the implant feedthrough for the Nucleus Hybrid L24 implant. |