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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantMEDTRONIC, INC.
PMA NumberP010015
Supplement NumberS205
Date Received05/29/2013
Decision Date04/10/2014
Product Code
NKE[ Registered Establishments with NKE ]
Docket Number 14M-0553
Notice Date 05/08/2014
Advisory Committee Cardiovascular
Clinical Trials NCT00267098
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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