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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 NumberS103
Date Received12/24/2012
Decision Date03/21/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for te sterile silicone template (sst) as a single use surgical tool to help check the size of the periosteal pocket, the shape and depth of the implant well, and appropriate positions for tie-down holes during the implant surgical procedure.
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