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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.
 
DeviceMED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS006
Date Received11/01/2002
Decision Date03/18/2003
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR BROADENING THE INDICATION OF THE C40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE CHILDREN AGED TWELVE MONTHS OR OLDER.
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