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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 NameCOMBI 40+ COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS035
Date Received06/25/2008
Decision Date12/19/2008
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the maestro system software version 3. 0 as external software for use with the med-el combi 40+ cochlear implant system, including removal of the current restriction regarding use of the fsp coding strategy by inexperienced adult users.
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