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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 FOR CHILDREN
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR AMERICAS
PMA NumberP890027
Supplement NumberS055
Date Received12/16/2002
Decision Date12/27/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the coil/cable of the esprit 3g speech processor to enable nucleus 22 users to access the technological benefits of the esprit 3g.
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