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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
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck A-602-6020
PMA NumberP000025
Supplement NumberS006
Date Received11/01/2002
Decision Date03/18/2003
Product Code
MCM[ Registered Establishments with 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 Product No
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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