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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 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS129
Date Received03/23/2015
Decision Date06/23/2015
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE CP900 SERIES PROCESSOR COILWHICH MAKES THE CP900 SERIES PROCESSOR COMPATIBLE WITH THE N22 IMPLANT AND ALLOWS RECIPIENTS OF THE N22 IMPLANT ACCESS TO THE NEWEST PROCESSOR TECHNOLOGY.
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