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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)
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS002
Date Received06/07/2002
Decision Date12/20/2002
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the commercial introduction of the contak renewal model h135 cardiac resynchronization therapy defibrillator (crt-d) and the model 2845 version 1. 7 software. The device, as modified, will be marketed under the trade name contak renewal and is indicated as follows: the contak renewal heart failure device system is indicated for use in the following: patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <35%) and qrs during >120 ms and remain symptomatic despite stable, optimal heart failure drug therapy. Patient populations at high risk of sudden cardiac death due to ventricular arrhythmias include, but are not limited to, those with: 1) survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia. 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note: the clinical outcome of hemodynamically stable, sustained-vt patients is not fully known. Safety and effectiveness studies have not been conducted. 3) prior myocardial infarction, left ventricular ejection fraction of <35%, and a documented episode of nonsustained vt, with an inducible ventricular tachyarrhythmia. 4) patients suppressible with iv procainamide or an equivalent antiarrhythmic (drug) have not been studied.