TPLC - Total Product Life Cycle

• Device: dura substitute
• Regulation Description: Dura substitute.
• Product Code: GXQ
• Regulation Number: 882.5910
• Device Class: 2

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

Device Problems
Leak	26
Other (for use when an appropriate device code cannot be identified)	16
Performance	9
Explanted	9
Sterility	5
No Known Device Problem	4
Device remains implanted	4
Rejection	3
Unknown (for use when the device problem is not known)	3
No Information	3
Degraded	2
Material disintegration	1
Error or warning message, failure to produce	1
Fracture	1
Material rupture	1
Device Issue	1
Protective measure issue	1
Total Device Problems	90

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp	II	Mar-16-2010
2	Integra LifeSciences Corp.	II	Nov-24-2010
3	Integra LifeSciences Corporation	II	May-10-2013