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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 MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantNUCLEUS, LTD.
PMA NumberP840024
Supplement NumberS022
Date Received07/19/1989
Decision Date10/11/1989
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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