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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 Drive
Centennial, CO 80124
PMA NumberP130016
Supplement NumberS016
Date Received02/08/2016
Decision Date09/01/2016
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus HybridL24 Implant System.
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