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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device barrier, absorable, adhesion
Product CodeMCN
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 3 2 5 8 4 3 1 2 2

Device Problems
No code available 20
Migration of device or device component 18
Other (for use when an appropriate device code cannot be identified) 14
No Known Device Problem 13
Unknown (for use when the device problem is not known) 7
Material erosion 7
Device Issue 1
Obstruction within device 1
No Information 1
Reaction 1
Total Device Problems 83

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 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Genzyme Corporation II Jun-21-2012

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