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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, vascular graft, of less then 6mm diameter
Regulation Description Vascular graft prosthesis.
Product CodeDYF
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
C.R. BARD, INC.
  1
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 4
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  3
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Leak 7
Torn material 4
Tears, rips, holes in device, device material 2
Occlusion within device 2
Foreign material present in device 2
Incompatibility problem 1
No Known Device Problem 1
Packaging issue 1
Replace 1
Material rupture 1
Suture line disruption 1
Other (for use when an appropriate device code cannot be identified) 1
Split 1
Explanted 1
Total Device Problems 26

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 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-30-2013

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