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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.
 
DeviceSPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1)
Generic NamePermanent defibrillator electrodes
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP920015
Supplement NumberS178
Date Received04/15/2016
Decision Date10/12/2016
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
Post-Approval StudyShow Report Schedule and Study Progress
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