CONTAK RENEWAL 3 AVT CRT-D SYSTEM

FDA premarket approval P010012/S037 · decided 2008-03-13

Approval details

PMA number

P010012

Supplement

S037

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CONTAK RENEWAL 3 AVT CRT-D SYSTEM

Generic name

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

Applicant

Boston Scientific Corp

Date received

2004-11-10

Decision date

2008-03-13

Days to decision

1219 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

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 ATRIA

510(k) clearances by this applicant