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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, impotence, mechanical/hydraulic
Regulation Description Penile inflatable implant.
Definition PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product CodeFHW
Regulation Number 876.3350
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 6 2 4 5 2 5 5 10 1

Device Problems
Implant, removal of 4
Device Issue 3
Explanted 3
Mechanical issue 1
Failure to pump 1
Unknown (for use when the device problem is not known) 1
Malfunction 1
Defective item 1
Device operates differently than expected 1
Deflation, cause unknown 1
Material erosion 1
Total Device Problems 18

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 1 0 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 Nov-10-2009

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