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

FDA premarket approval P010012/S014 · decided 2003-10-21

Approval details

PMA number

P010012

Supplement

S014

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

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

Generic name

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

Applicant

Boston Scientific Corp

Date received

2003-06-20

Decision date

2003-10-21

Days to decision

123 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

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

510(k) clearances by this applicant