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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.
 
DeviceMi1210 SYNCHRONY ST Cochlear Implant
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS103
Date Received07/18/2018
Decision Date01/22/2019
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Mi1210 SYNCHRONY ST Cochlear Implant +Standard, +Medium, +Compressed, +FLEXSOFT, +FLEX24, +FLEX28 (for non-EAS patients), the Mi1210 SYNCHRONY ST Cochlear Implant +FLEX20, +FLEX24 (for EAS patients), the Mi1210 Implant Template, and associated surgical accessories.
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