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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 24 COCHLEAR IMPLANT SYSTEM WITH STYLET REPLACEMENT TOOL
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS020
Date Received06/13/2002
Decision Date06/20/2002
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 a stylet replacement tool.
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