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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 FOR ADULTS AND CHILDREN
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system
ApplicantCOCHLEAR CORP.
PMA NumberP970051
Supplement NumberS016
Date Received04/19/2001
Decision Date07/24/2001
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the crystal integrity test system that provides a way of performing a series of integrity checks on either current or past generation nucleus cochlear implants.
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