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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device absorbable lung biopsy plug
Regulation Description Absorbable lung biopsy plug.
Definition A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.
Product CodeOMT
Regulation Number 878.4755
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIOTECH
  GRANTED 1

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 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Surgical Specialties Mexico S DE RL DE CV II Oct-11-2016

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