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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 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 NumberS009
Date Received09/24/2014
Decision Date04/08/2015
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: 1) ADDITION OF THE IMPLANT EAR, ELECTRIC ONLY TEST CONDITION, AND 2) MODIFICATION OF THE TESTING SCHEDULE TO INCLUDE A TIERED APPROACH.
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