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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
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS054
Date Received06/20/2011
Decision Date04/20/2012
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE PACKAGING CONFIGURATION OF YOUR SONATATI100 COCHLEAR IMPLANT AND THE IMPLANT TEMPLATE, SINGLE USE, FOR THE SONATATI100. THIS CHANGE WILL ENABLE THE SONATA SINGLE USE TEMPLATE TO BE SHIPPED TOGETHER WITH THE SONATATI100 COCHLEAR IMPLANT INSIDE THE IMPLANT BOX.
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