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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 NameMODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS004
Date Received08/01/2002
Decision Date10/07/2002
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the models h115 and h119 contak cd 2 cardiac resynchronization therapy defibrillator (crt-d). The contak cd 2 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. Patients 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 hymodynamically 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.
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