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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP000022
Date Received05/30/2000
Decision Date10/16/2000
Withdrawal Date 12/21/2006
Product Code MAF 
Docket Number 01M-0039
Notice Date 01/31/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC AVE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) CORONARY STENT DELIVERY SYSTEM AND THE MEDTRONIC AVE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
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