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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 AUDITORY BRAINSTEM IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP000015
Supplement NumberS006
Date Received03/09/2005
Decision Date03/30/2005
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE OF SUPPLIER FOR THREE SILICONE PRODUCTS (SILICONE HCRP 50, SILICONE LSR 30, AND RTV SILICONE ADHESIVE) AND CHANGE THE CATALYST IN TWO ADDITIONAL SILICONE PRODUCTS (MED4515 & MED4516).
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