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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 NumberS104
Date Received01/16/2013
Decision Date10/23/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: a modification to the freedom sound processor, a change in the freedom bodyworn cable o-ring, a change to freedom bodyworn cable clip, a change to the freedom battery pack, a change to the freedom rechargeable battery, and a modification of the surgical tool kit instructions for the ci24re and ci422 series implants.
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