Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S136 |
Date Received | 10/23/2015 |
Decision Date | 11/20/2015 |
Product Code |
MCM |
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 THE INTRODUCTION OF AN ADDITIONAL CLEANING STEP TO REMOVE PRIMER RESIDUE PRIOR TO CURING FROM THE WELD SURFACE OF THE NUCLEUS CI 500 SERIES IMPLANTS (NUCLEUS CI512 AND 522). |
|
|