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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 22 COCHLEAR IMPLANT SYSTEM- CHILDREN
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR CORP.
PMA NumberP890027
Supplement NumberS049
Date Received11/29/2000
Decision Date01/16/2001
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the firmware, components and labeling of the portable programming system (pps) with no change to the currently approved indications for use.
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