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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 COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS078
Date Received06/24/2011
Decision Date07/21/2011
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to: 1) the test systems (acoustic and wireless) to update test equipment and firmware; 2) additional tests for the digital sound processing memory; 3) modification to test limits; and 4) minor changes to the system user interface and test report format.
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