PMA P010012S014

Device

CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)

Applicant

Boston Scientific Corp

PMA number

P010012

Supplement

S014

Product code

NIK

Decision date

2003-10-21

Classification

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Approval order statement

APPROVAL FOR AN EXPANDED INDICATION FOR YOUR MARKETED CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES. THE DEVICES ARE 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 TACHYARRHYTHMIA. PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC DRUG HAVE NOT BEEN STUDIED. 4) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30%.