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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dura substitute
Regulation Description Dura substitute.
Product CodeGXQ
Regulation Number 882.5910
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 3
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
SHELHIGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Leak 32
No Known Device Problem 27
Other (for use when an appropriate device code cannot be identified) 16
No code available 9
Performance 9
Explanted 9
No Information 7
Failure to separate 5
Device operates differently than expected 5
Sterility 5
Device remains implanted 5
Fluid leak 4
Rejection 3
Unknown (for use when the device problem is not known) 3
Torn material 3
Use of Device Issue 2
Degraded 2
Sticking 2
Device inoperable 1
Product quality issue 1
Difficult to remove 1
Repair 1
Material rupture 1
Material separation 1
Material disintegration 1
Error or warning message, failure to produce 1
Device expiration issue 1
Fracture 1
Failure to Adhere or Bond 1
Break 1
Component missing 1
Device Issue 1
Protective measure issue 1
Total Device Problems 163

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 2 0 0 2 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp II Mar-11-2010
2 Integra LifeSciences Corp. II Nov-24-2010
3 Integra LifeSciences Corporation II May-10-2013
4 Synovis Surgical Innovations, Inc. II Nov-18-2013

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