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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.
 
DeviceCOMBI 40+ COCHLEAR IMPLANT SYSTEM
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS082
Date Received09/04/2015
Decision Date12/03/2015
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE TO THE MAGNET MATERIAL USED TO MANUFACTURETHE MI1200 SYNCHRONY MAGNET ASSEMBLIES AND THE MI1200 REPLACEMENT MAGNETS. THE CHANGE IS INTENDED TO REPLACE THE CURRENTLY USED MAGNET MATERIAL WHICH IS DISCONTINUED BY THESUPPLIER.
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