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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, angioplasty, laser, coronary
Product CodeLPC
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1 1 3 4 10 11 5 7 7 7 3

Device Problems
No Information 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corp. II Apr-11-2012
2 Spectranetics Corporation II Nov-28-2016

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