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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™ Nucleus® System
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS237
Date Received08/01/2025
Decision Date09/02/2025
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This revision includes data from an IDE study (G190269) to complete the pediatric recruitment arm of this PAS. These additional data are from 23 subjects whose audiometric inclusion criteria overlap with the inclusion criteria for this PAS.
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