PMA P010012S037

Device

CONTAK RENEWAL 3 AVT CRT-D SYSTEM

Applicant

Boston Scientific Corp

PMA number

P010012

Supplement

S037

Product code

NIK

Decision date

2008-03-13

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 THE CONTAK RENEWAL 3 AVT AND CONTAK RENEWAL 3 AVT HE SYSTEMS. THE SYSTEMS ARE INDICATED FOR THE FOLLOWING: CONTAK RENEWAL 3 AVT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS. CONTAK RENEWAL 3 AVT PROVIDES ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT FOR PATIENTS WITH A HISTORY OF OR WHO ARE AT RISK OF DEVELOPING ATRIAL ARRHYTHMIAS.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P010012S037B.pdf" target="_new">Summary of Safety and Effectiveness</a>