MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM

FDA premarket approval P010012/S004 · decided 2002-10-07

Approval details

PMA number

P010012

Supplement

S004

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM

Generic name

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

Applicant

Boston Scientific Corp

Date received

2002-08-01

Decision date

2002-10-07

Days to decision

67 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

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 C

510(k) clearances by this applicant