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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device balloon, epistaxis
Regulation Description Epistaxis balloon.
Product CodeEMX
Regulation Number 874.4100
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMATRIX
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEROCEL
  SUBSTANTIALLY EQUIVALENT 2
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 5
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 2
Air leak 1
Deflation issue 1
Total Device Problems 4

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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