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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 NumberS050
Date Received12/27/2010
Decision Date07/22/2011
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 an updated version of the med-el combi 40+ cochlear implant system referred to as maestro 2010 consisting of the following features: 1) a thinner version of the sonatati- 100 cochlear implant, the mi1000 med-el concert; 2) several design and manufacturing updates related to the introduction of the mi1000 medel concert; 3) new tasks and functionalities added to the maestro fitting software in maestro 4. 0; 4) a selection of new colors available for the opus 2 audio processor and; 5) a new, more energy-efficient, audio processor coil called d-coil.
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