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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.
 
DeviceCOCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS139
Date Received12/17/2015
Decision Date01/15/2016
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
Approval Order Statement  
ADDITION OF AN AUTOMATED MICROBLAST DEFLASHING OF THE FEEDTHROUGH FOR THE CI500 SERIES COCHLEAR IMPLANTS.
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