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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS063
Date Received08/10/2012
Decision Date06/06/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
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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