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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNUCLEUS HYBRID L24 IMPLANT SYSTEM
Classification Namehybrid cochlear implant
ApplicantCOCHLEAR AMERICAS
PMA NumberP130016
Supplement NumberS009
Date Received09/24/2014
Decision Date04/08/2015
Product Code
PGQ[ Registered Establishments with PGQ ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
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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