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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 24 COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS052
Date Received07/22/2009
Decision Date12/10/2009
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a number of manufacturing changes to include: 1) cosmetic changes to improve the adhesion of the paint to the battery can; 2) housing changes to improve the durability of the battery and to increase the strength of the can; and 3) changes in the welding process to improve ultrasonic weld strength and to reduce weld failures.
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