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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.
 
DeviceMI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS091
Date Received09/22/2016
Decision Date12/20/2016
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to allow a maximum of four re-sterilization cycles after initial sterilization for the following products: Mi1200 SYNCHRONY (PIN) Cochlear Implant, Mi1000 MED-EL CONCERT (PIN) Cochlear Implants, SONATATI100 Cochlear Implants, Insertion Electrodes (IE) and Insertion Test Device (ITD).
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