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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 L24 Cochlear Implant System
Generic NameCochlear implant with combined electrical stimulation and acoustic amplification
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP130016
Supplement NumberS051
Date Received09/07/2022
Decision Date12/06/2022
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Cochlear Nucleus® MRI Kit, an accessory, together with associated labeling changes, to allow certain Nucleus implant recipients to undergo MRI scans at 1.5 T with the implant magnet in place.
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