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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Nameheart failure device/implantable coronary venous steroid-eluding pace/sense lead and accessories
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP010012
Date Received02/27/2001
Decision Date05/02/2002
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 02M-0236
Notice Date 05/22/2002
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the contak cd crt-d system and the easytrak coronary venous steroid-eluding single-electrode pace/sense lead, models 4510, 4511, 4512 and 4513. The contak cd crt-d system is indicated for 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 duration >= 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 tachy-arrhythmia. Patients suppressible with iv procainamide or an equivalent antiarrhythmic (drug) have not been studied. The easytrak coronary venous steroid-eluding single-electrode pace/sense lead, models 4510, 4511, 4512 and 4513 are transvenous leads intended for chronic left ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible guidant cardiac resynchronization therapy (crt) device.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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