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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device replacement, ossicular prosthesis, total
Regulation Description Total ossicular replacement prosthesis.
Product CodeETA
Regulation Number 874.3495
Device Class 2


Premarket Reviews
ManufacturerDecision
AUDIO TECHNOLOGIES S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GRACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEINZ KURZ GMBH MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 2
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Material separation 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Heinz Kurz GmbH Medizintechnik II Jun-30-2011

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