|
Device | NUCLEUS COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S070 |
Date Received | 05/16/2011 |
Decision Date | 08/30/2011 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE TO THE DIAMETER SPECIFICATION OF THE WIRE USED IN THE ELECTRODES OF THE COCHLEAR IMPLANT SYSTEM. |