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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 C40+ COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS031
Date Received01/23/2008
Decision Date04/18/2008
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATIONS AS FOLLOWS: 1) ADAPTION OF ENCLOSED TESTS AT HEADER INCOMING INSPECTION; 2) CHANGE IN INCOMING INSPECTION PROCEDURE FOR CABLES OF REMOTE BATTERY PACK; 3) INTRODUCTION OF SILICONE MIXING MACHINE; 4)CHANGE IN MANUFACTURING PROCEDURE FOR WELDING OF COIL; 5) ALTERNATIVE EQUIPMENT TO MEASURE STRENGTH OF MAGNETS; 6) CHANGES TO ELECTRODE MOULDS; 7) CHANGE IN SPRINT; AND 8) NEW MOULD SHAPE.
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