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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 Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
PMA NumberP960040
Supplement NumberS028
Date Received08/05/2002
Decision Date03/27/2003
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 05M-0435
Notice Date 10/31/2005
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the vantak prizm avt aicd system. The device is indicated for use in the following: patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias. Patient populations who are indicated for a guidant icd include: 1) those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction <=30% (as defined in the madit ii clinical study appendix).
Approval Order Approval Order