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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 NumberS019
Date Received06/15/2016
Decision Date10/28/2016
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.
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