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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 NumberS073
Date Received05/19/2011
Decision Date09/27/2011
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for widening the acceptance window for the input frequency manufacturing test for the nucleus freedom bte speech processor.
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