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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS037
Date Received11/10/2004
Decision Date03/13/2008
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 08M-0243
Notice Date 04/24/2008
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling