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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 CHANNEL COCHLEAR
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP840024
Supplement NumberS046
Date Received08/28/1992
Decision Date08/21/1995
Product Code MCM 
Docket Number 95M-0398
Notice Date 12/19/1995
Advisory Committee Ear Nose & Throat
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR NUCLEUS 22-CHANNEL COCHLEAR IMPLANT FOR USE IN AN EXPANDED ADULT POPULATION.
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