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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS052
Date Received07/22/2009
Decision Date12/10/2009
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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