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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTRASTENT DOUBLESTRUT STENT
Generic NameSTENT, ILIAC
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP030045
Supplement NumberS002
Date Received10/30/2013
Decision Date04/16/2015
Product Code NIO 
Advisory Committee Cardiovascular
Clinical TrialsNCT01402700
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A DESIGN MODIFICATION TO THE INTRASTENT DOUBLESTRUT STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISI-PRO BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITHA REFERENCE VESSEL DIAMETER OF 5 TO 10 MM.
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