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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 Cochlear Implant System
Generic NameImplant, cochlear
ApplicantMed-El Corp.
Furstenweg 77a
Innsbruck 6020
PMA NumberP000025
Supplement NumberS116
Date Received05/27/2020
Decision Date08/25/2020
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the RONDO 3 Audio Processor, MAESTRO System Software 9.0, and WaterWear for RONDO 3.
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