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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMED-EL COCHLEAR IMPLANT SYSTEMS
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS039
Date Received03/04/2009
Decision Date04/30/2009
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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