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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.
 
Trade NameCONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS017
Date Received11/13/2003
Decision Date02/06/2004
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the indications for use and clinical study section labeling. The devices are indicated for: for icds (ventak prx, mini, vitality, ventak av and prizm): guidant icds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. For vitality avt: guidant vitality avt is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. For crt-ds (contak cd and renewal): guidant cardiac resynchronization therapy defibrillators (crt-ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Guidant crt-ds are also indicated for reduction of symptoms of moderate to severe heart failure (nyha iii/iv) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms.
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