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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.
 
DeviceMED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck A-602-6020
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/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN UPDATED VERSION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANTSYSTEM 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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