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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, vocal cord medialization
Regulation Description Ear, nose, and throat synthetic polymer material.
Product CodeMIX
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFORM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COAPT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CYTOPHIL INC
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 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 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Merz North America, Inc. II Dec-03-2015

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