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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 NumberS043
Date Received01/14/2020
Decision Date02/21/2020
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
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 changes to MR Conditional labeling for CI24REH, CI24RE and CI500 Series Cochlear Implants.
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