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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
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS004
Date Received08/20/2002
Decision Date09/04/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification to replace combi 40+ cochlear implant system "insertion electrode" with the insertion test device (itd). The device, as modified, will be marketed under the trade name med-el insertion test device and is indicated for individuals undergoing cochlear implant surgeries after a mastoidectomy, posterior tympanotomy, and cochleostomy have been performed and where access to the cochlea has been secured.
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