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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 NameVENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Name1856, ventak prizm vr/dr he models 1852/1853, ventak mini iv models 1790/1793/1796 and ventak mini iii he model 1789.
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS037
Date Received12/14/2001
Decision Date07/18/2002
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 02M-0352
Notice Date 08/08/2002
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ventak prizm 2 vr/dr models 1860/1861, ventak prizm vr/dr models 1850/1851/1855/ 1856, ventak prizm vr/dr he models 1852/1853, ventak mini iv models 1790/1793/1796 and ventak mini iii he model 1789. These devices are indicated in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias. In addition, these devices are indicated for prophylactic treatment of patients with a prior myocardial infarction and an ejection fraction (ef) <=30% (as defined in the clinical study section).
Approval Order Approval Order
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