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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Definition To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Product CodeNWX
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
4 1 4 2 5 0 1

Device Problems
Retraction problem 2
Detachment of device component 2
Difficult to remove 1
Replace 1
Break 1
Material rupture 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Detachment of device or device component 1
Total Device Problems 11

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

Recalls
Manufacturer Recall Class Date Posted
1 AngioScore Inc. I Aug-18-2010
2 AngioScore Inc. III Jan-23-2008

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