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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 24 Cochlear Implant System
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS159
Date Received03/23/2017
Decision Date04/21/2017
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternate Printed Circuit Board (PCB) supplier for the CP800 and CP900 sound processor coils for the Nucleus 24 Cochlear Implant system, the Nucleus Hybrid L24 implant system and the Nucleus ABI541 Auditory Brainstem Implant system.
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