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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device barrier, adhesion, cardiovascular
Definition Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.
Product CodeOBD
Device Class 3

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

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