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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 Hybrid Cochlear Implant System
Generic NameCochlear implant with combined electrical stimulation and acoustic amplification
ApplicantCochlear Americas
10350 Park Meadows Drive
Centennial, CO 80124
PMA NumberP130016
Supplement NumberS027
Date Received05/16/2017
Decision Date06/13/2017
Product Code PGQ 
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  
Introduction of the new CBO Sprint Cleanroom at the Cochlear Brisbane Operations (CBO) manufacturing site.
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