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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.
 
DeviceCARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS309
Date Received04/11/2014
Decision Date07/03/2014
Product Code NVZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00980057
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE VIVA/BRAVA QUADRIPOLAR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES AND IS INDICATED FOR PATIENTS WHO REQUIRE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE- THREATENING VENTRICULAR ARRHYTHMIAS, FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS AND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND MEET ANY OF THE CLASSIFICATIONS PROVIDED IN THE LABELING.
Approval OrderApproval Order
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