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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, incontinence, mechanical/hydraulic
Regulation Description Implanted mechanical/hydraulic urinary continence device.
Definition PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
Product CodeEZY
Regulation Number 876.5280
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
6 6 7 6 4 8 2 4 9 1

Device Problems
Mechanical issue 2
Implant, removal of 2
Material erosion 1
Migration of device or device component 1
Replace 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 0 1 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II May-10-2013
2 American Medical Systems, Inc. II Jun-27-2011

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