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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck A-602-6020
PMA NumberP000025
Supplement NumberS007
Date Received12/10/2002
Decision Date06/05/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF AN INDICATION FOR USE ALLOWING THE USE OF MAGNETIC RESONANCE IMAGING (MRI) AT 0.2 TESLA FOR PATIENTS IMPLANTED WITH COMBI 40+ COCHLEAR IMPLANTS (C40+, C40+S AND C40+GB ELECTRODE ARRAYS).
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