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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, testicular
Regulation Description Testicular prosthesis.
Definition Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
Product CodeFAF
Regulation Number 876.3750
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 1 0 1 0 0 0 0 0 0

Device Problems
Leak 2
Material rupture 1
Device damaged prior to use 1
Break 1
Explanted 1
Hole in material 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Dec-27-2010

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