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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- ADULTS
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP840024
Supplement NumberS080
Date Received11/29/2000
Decision Date01/16/2001
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 MODIFICATION TO THE FIRMWARE, COMPONENTS AND LABELING OF THE PORTABLE PROGRAMMING SYSTEM (PPS) WITH NO CHANGE TO THE CURRENTLY APPROVED INDICATIONS FOR USE.
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