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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR CHILDREN/ESPRIT 22
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP890027
Supplement NumberS051
Date Received09/28/2001
Decision Date02/19/2002
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A RESISTOR TO THE INTEGRATED CIRCUIT FOR THE ESPRIT 22 SPEECH PROCESSOR.
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