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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 LEAD
Generic NamePermanent defibrillator electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP830061
Supplement NumberS086
Date Received03/13/2013
Decision Date02/18/2014
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE DEXAMETHASONE SODIUM PHOSPHATE (DSP) COATING FROM THE LEAD TIP AND THE MANUFACTURING SITE CHANGE FOR THE MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) FOR THE CAPSURE SENSE FAMILY OF LEADS.
Approval OrderApproval Order
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