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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, superficial femoral artery, drug-eluting
Definition Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product CodeNIU
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
0 0 0 0 0 1 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 1
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cook, Inc. I May-15-2013

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