|
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 | S001 |
Date Received | 03/28/2014 |
Decision Date | 04/25/2014 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Clinical Trials | NCT00678899
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ACCEPTANCE OF A SUPPLIER MANUFACTURING PROCESS CHANGE. |
Post-Approval Study | Show Report Schedule and Study Progress |