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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® Auditory Brainstem Implant
Generic NameImplant, auditory brainstem
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP000015
Supplement NumberS052
Date Received11/13/2023
Decision Date12/13/2023
Product Code MHE 
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  
introduction of new manufacturing processes for making battery subcomponents of the CP1000 and CP1100 sound processors
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