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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+
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck A-602-6020
PMA NumberP000025
Supplement NumberS010
Date Received06/16/2003
Decision Date07/25/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE THE FOLLOWING ACCESSORIES FOR THE TEMPO+ SPEECH PROCESSOR: TELEMIC AND MICROPHONE TEST DEVICE (MTD). THE TELEMIC IS INDICATED FOR THE COMBI 40+ COCHLEAR IMPLANT USER WHO DESIRES EITHER A DIRECT CONNECTION TO A TELEPHONE OR AN INDUCTION LOOP OR ADDITIONAL AMPLIFICATION OF THE TEMPO+ SPEECH PROCESSOR INTERNAL MICROPHONE. THE MTD IS INDICATED FOR INDIVIDUALS WHO WISH TO QUALITATIVELY MONITOR THE MICROPHONE SIGNAL OF THE TEMPO+ SPEECH PROCESSOR.
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