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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.
 
DeviceMi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
Generic NameImplant, cochlear
ApplicantMed-El Corp.
Furstenweg 77a
Innsbruck 6020
PMA NumberP000025
Supplement NumberS114
Date Received03/30/2020
Decision Date09/25/2020
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the 1) Mi1260 SONATA 2 (with S-Vector Magnet); 2) optional tool S-Vector Magnet Replacement Kit; and 3) new S-Vector Magnet for use with the approved Mi1250 SYNCHRONY 2 (PIN).
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