|
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 | S052 |
Date Received | 07/22/2009 |
Decision Date | 12/10/2009 |
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 NUMBER OF MANUFACTURING CHANGES TO INCLUDE: 1) COSMETIC CHANGES TO IMPROVE THE ADHESION OF THE PAINT TO THE BATTERY CAN; 2) HOUSING CHANGES TO IMPROVE THE DURABILITY OF THE BATTERY AND TO INCREASE THE STRENGTH OF THE CAN; AND 3) CHANGES IN THE WELDING PROCESS TO IMPROVE ULTRASONIC WELD STRENGTH AND TO REDUCE WELD FAILURES. |