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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 FOR ADULTS
Classification Nameimplant, cochlear
Generic Namecochlear implant (adult)
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS081
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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