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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device graft, vascular, synthetic/biologic composite
Regulation Description Vascular graft prosthesis.
Product CodeMAL
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device remains implanted 22
Leak 19
Hole in material 7
Unknown (for use when the device problem is not known) 5
Material puncture 4
Tears, rips, holes in device, device material 2
Other (for use when an appropriate device code cannot be identified) 2
Implant, removal of 1
Deterioration of prosthesis 1
Structural problem 1
Device, removal of (non-implant) 1
Delamination 1
Torn material 1
Repair 1
Replace 1
Contamination during use 1
Elective replacement 1
Foreign material 1
Material frayed 1
Total Device Problems 73

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

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular, LLC II Jul-22-2010

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