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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.
 
DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP010015
Supplement NumberS205
Date Received05/29/2013
Decision Date04/10/2014
Product Code NKE 
Docket Number 14M-0553
Notice Date 05/08/2014
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE CRT-P AND CRT-D DEVICES TO INCLUDE NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) => 50% ARE ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT IS EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING. THESE DEVICES ARE INDICATED FOR THE FOLLOWING: THE CONSULTA CRT-P SYSTEM IS INDICATED FOR: 1) NYHA FUNCTIONAL CLASS III AND IV PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY AND HAVE A LVEF =< 35% AND A PROLONGED QRS DURATION; AND 2) NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LVEF =<50% ARE ON STABLE OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT ARE EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING. FOR ADDITIONAL INFORMATION PLEASE REFER TO APPROVAL ORDER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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