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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.
Classification Namepulse generator, permanent, implantable
PMA NumberP890003
Supplement NumberS329
Date Received03/16/2015
Decision Date09/11/2015
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the evera mri xt/s dr and vr implantable cardioverter defibrillator devices and programmer application software model sw033 as well as extension of mr conditional labeling and use for sprint quattro secure lead models 6935m and 6947m as mri surescan labeled 55 and 62cm leads. In addition to the system components listed, the use of the capsurefix mri surescan lead model 5086mri and capsurefix novus mri surescan lead model 5076 with the evera mri dr (dual chamber) system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use carelink monitor model 2490c, carelink express monitor 2020b, cardiosight reader model 2020a, mycarelink monitor model 24950 and device data management application (ddma) model 2491 to provide patient and device data transfer from the evera mri devices.
Post-Approval StudyShow Report Schedule and Study Progress