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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device splint, intranasal septal
Regulation Description Intranasal splint.
Product CodeLYA
Regulation Number 874.4780
Device Class 1


Premarket Reviews
ManufacturerDecision
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
Hemostasis, LLC
  SUBSTANTIALLY EQUIVALENT 1
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEROCEL
  SUBSTANTIALLY EQUIVALENT 2
OASIS
  SUBSTANTIALLY EQUIVALENT 1
POLYGANICS BV
  SUBSTANTIALLY EQUIVALENT 3
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEIKAGAKU CORP., TAKAHAGI PLANT
  SUBSTANTIALLY EQUIVALENT 1
SILIMED
  SUBSTANTIALLY EQUIVALENT 1
SINEXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 6
Obstruction within device 3
Residue after decontamination 2
Packaging issue 2
Device operates differently than expected 2
No code available 2
Material integrity issue 1
No Information 1
Improper or incorrect procedure or method 1
Patient-device incompatibility 1
Total Device Problems 21

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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