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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.
 
DeviceMEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
3576 UNO CAL PLACE
SANTA ROSA, CA 95403
PMA NumberP960010
Date Received05/01/1996
Decision Date06/27/1997
Withdrawal Date 06/09/2008
Product Code MAF 
Docket Number 98M-0726
Notice Date 09/09/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC WIKTOR(R) PRIME CORONARY STENT DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN NATIVE CORONARY ARTERIES AND BYPASS GRAFT VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 3.0 TO 4.5 MM.
Supplements:  S001 
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