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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 Namestent, iliac
Generic Namevascular stent
PMA NumberP030045
Supplement NumberS002
Date Received10/30/2013
Decision Date04/16/2015
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Clinical Trials NCT01402700
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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, with a reference vessel diameter of 5 to 10 mm.