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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.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS381
Date Received05/29/2013
Decision Date04/10/2014
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 14M-0553
Notice Date 05/08/2014
Advisory Committee Cardiovascular
Clinical Trials NCT00267098
Supplement Typepanel 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 consulta crt-d model d224trk, concerto ii crt-d model d274trk, consulta crt-d model d204trm, protecta xt crt-d model d314trm, protecta crt-d model d334trm, protecta xt crt-d model d314trg, protecta crt-d model d334trg, viva xt crt-d model dtba1d4, viva xt crt-d model dtba1d1, viva s crt-d model dtbb1d4, and viva s crt-d model dtbb1d1: for additional information please refer to the approval order.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2