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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 2017
1 3 2 5 8 4 3 1 2 7 1

Device Problems
No code available 52
Migration of device or device component 23
No Known Device Problem 21
Other (for use when an appropriate device code cannot be identified) 14
Unknown (for use when the device problem is not known) 7
Material erosion 7
Incomplete or missing packaging 1
Device Issue 1
Obstruction within device 1
No Information 1
Reaction 1
Total Device Problems 129

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 0 0
Class III 0 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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