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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.
 
DeviceNUCLEUS COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS074
Date Received05/19/2011
Decision Date08/30/2011
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to move the inner and outer moulding process of a transformer pod in-house, and modify the shape of the inner-mould.
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