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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insert, tubal occlusion
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
Definition Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product CodeHHS
Regulation Number 884.5380
Device Class 3

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

Device Problems
Malposition of device 3
Capturing issue 2
No Information 2
Loose or intermittent connection 2
Oversensing 1
Slippage of device or device component 1
Tip breakage 1
Undersensing 1
Low impedance 1
Misfire 1
Premature discharge of battery 1
Break 1
Failure to deploy 1
Entrapment of device or device component 1
Deployment issue 1
Device operates differently than expected 1
Extrusion 1
Positioning Issue 1
Total Device Problems 23

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