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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 CI500 SERIES IMPLANTS
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS135
Date Received10/13/2015
Decision Date11/12/2015
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
NEW SUPPLIER AND A CHANGE IN THE UPPER TOLERANCE SPECIFICATION OF THE 25 MICRON PLATINUM IRIDIUM WIRE.
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