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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 COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS047
Date Received04/30/2010
Decision Date09/03/2010
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type135 review track for 30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the production of the thermoforming foil used to produce the blisters of the sterile package for the cochlear implants.
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