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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.
 
DeviceCOMBI 40+ COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantMed-El Corp.
Furstenweg 77a
Innsbruck 6020
PMA NumberP000025
Supplement NumberS135
Date Received03/25/2025
Decision Date04/24/2025
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
introduction of an additional laser welding system for the hermetic weld and bakeout of MED-EL Cochlear Implants
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