CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

FDA premarket approval P010012/S002 · decided 2002-12-20

Approval details

PMA number

P010012

Supplement

S002

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Generic name

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

Applicant

Boston Scientific Corp

Date received

2002-06-07

Decision date

2002-12-20

Days to decision

196 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

APPROVAL FOR THE COMMERCIAL INTRODUCTION OF THE CONTAK RENEWAL MODEL H135 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE MODEL 2845 VERSION 1.7 SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL AND IS INDICATED AS FOLLOWS: THE CONTAK RENEWAL HEART FAILURE DEVICE SYSTEM IS INDICATED FOR USE IN THE FOLLOWING: PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA

510(k) clearances by this applicant