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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, tympanostomy
Regulation Description Tympanostomy tube.
Product CodeETD
Regulation Number 874.3880
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ADEPT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GRACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
HEINZ KURZ GMBH MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 13

Device Problems
Electro-magnetic interference (EMI) 1
No Known Device Problem 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 2 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus ACMI Corporation I Mar-04-2010
2 Gyrus Acmi, Incorporated II Nov-20-2012
3 Micromedics, Inc. I Nov-18-2010

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