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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device absorbable collagen hemostatic agent with thrombin
Regulation Description Absorbable hemostatic agent and dressing.
Definition Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Product CodePMX
Regulation Number 878.4490
Device Class 3

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

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