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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agent, bulking, injectable for gastro-urology use
Product CodeLNM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
19 26 18 9 10 12 12 16 7 3

Device Problems
No Known Device Problem 105
Not Applicable 16
Normal 16
No code available 14
Misapplication 10
Device remains implanted 8
Migration of device or device component 7
No Information 7
Break 4
Incorrect or inadequate result 3
Implant extrusion 3
Unknown (for use when the device problem is not known) 3
Patient-device incompatibility 2
Calcified 2
Material erosion 1
Explanted 1
Shelf life exceeded 1
Device operates differently than expected 1
Malposition of device 1
Other (for use when an appropriate device code cannot be identified) 1
Therapeutic or diagnostic output failure 1
Total Device Problems 207

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 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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