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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 NumberS057
Date Received10/14/2011
Decision Date04/30/2012
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1) +flex28, +flex24 and flex24 electrode variants for the sonatati100 and mil000 med-el concert cochlear implants; 2) +standard, +medium and +compressed electrode variants for the sonatati100 cochlear implant; and 3) new variants of the single use surgical insertion electrode tool (standard, medium, compressed, flex24 and flex28).
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