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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.
 
DeviceCAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574.
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP830061
Supplement NumberS129
Date Received04/15/2016
Decision Date10/12/2016
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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