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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 C40+ COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS031
Date Received03/20/2008
Decision Date04/18/2008
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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