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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 SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS063
Date Received08/10/2012
Decision Date06/06/2013
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
Approval Order Statement  
APPROVAL FOR NEW LABELING THAT DESCRIBES CONDITIONS FOR SAFE MAGNETIC RESONANCE (MR) IMAGING AT 0.2 AND 1.5 TESLA FIELD STRENGTHS AND RADIATION THERAPY OF PATIENTS IMPLANTED WITH THE MED-EL COCHLEAR IMPLANT SYSTEMS WHICH INCLUDE THE PULSARCI100, SONATATI100, MED-EL CONCERT, MED-EL CONCERT PIN IMPLANTS.
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