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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)
4100 hamline avenue north
st. paul, MN 55112
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling