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. |
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Device | CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S205 |
Date Received | 05/29/2013 |
Decision Date | 04/10/2014 |
Product Code |
NKE |
Docket Number | 14M-0553 |
Notice Date | 05/08/2014 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00267098
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Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
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