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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 COCHLEAR IMPLANT SYSTEMS
Generic NameImplant, cochlear
ApplicantMed-El Corp.
Furstenweg 77a
Innsbruck 6020
PMA NumberP000025
Supplement NumberS039
Date Received02/18/2009
Decision Date04/30/2009
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
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 CHANGES MADE TO THE FOLLOWING USER MANUALS: DIB II (DIAGNOSTIC INTERFACE BOX), OPUS 1, OPUS 2 AND TEMPO+ SPEECH PROCESSORS, RBP (REMOTE BATTERY PACK) AND MICROPHONE TEST DEVICE (MTD).
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