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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.
 
DeviceHybrid Implant System
Generic NameCochlear implant with combined electrical stimulation and acoustic amplification
ApplicantCochlear Americas
10350 Park Meadows Drive
Centennial, CO 80124
PMA NumberP130016
Supplement NumberS044
Date Received10/02/2020
Decision Date12/30/2020
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new in-house terminal sterilization process to be used with a new sterilizer.
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