CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

FDA premarket approval P010012 · decided 2002-05-02

Approval details

PMA number

P010012

Trade name

CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Generic name

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

Applicant

Boston Scientific Corp

Date received

2001-02-27

Decision date

2002-05-02

Days to decision

429 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

Yes

Location

St Paul, MN

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 THER

510(k) clearances by this applicant