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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device occluder, patent ductus, arteriosus
Product CodeMAE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
13 6 9 7 7 6 5 3 2 5

Device Problems
Migration of device or device component 10
Size incorrect for patient 3
Premature deployment 2
Deployment issue 2
Dislodged or dislocated 2
Device operates differently than expected 1
Recannulation 1
Device remains implanted 1
Device, removal of (non-implant) 1
Malposition of device 1
Explanted 1
Difficult to insert 1
Leak 1
Total Device Problems 27

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


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