TPLC - Total Product Life Cycle

• Device: device, monitoring, intracranial pressure
• Regulation Description: Intracranial pressure monitoring device.
• Product Code: GWM
• Regulation Number: 882.1620
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
CMA MICRODIALYSIS AB
	SUBSTANTIALLY EQUIVALENT	4
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	7
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	3
DIAMETRICS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
INNERSPACE, INC.
	SUBSTANTIALLY EQUIVALENT	6
INTEGRA
	SUBSTANTIALLY EQUIVALENT	11
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	3
MEDEX
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
PMT CORP.
	SUBSTANTIALLY EQUIVALENT	1
RAUMEDIC AG
	SUBSTANTIALLY EQUIVALENT	3
SOPHYSA SA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Other (for use when an appropriate device code cannot be identified)	176
Pressure sensor failure	32
Break	29
Leak	7
Increase in pressure	5
Migration of device or device component	4
Defective component	2
Detachment of device component	1
Device, or device fragments remain in patient	1
Difficult to remove	1
Tube(s), buckling of	1
Wire(s), breakage of	1
Crack	1
Explanted	1
Total Device Problems	262

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra Neuro Sciences	II	Aug-05-2008
2	Codman & Shurtleff, Inc.	II	Mar-22-2012
3	Codman & Shurtleff, Inc.	II	Jan-11-2012
4	Codman & Shurtleff, Inc.	II	Apr-20-2011
5	Integra LifeSciences Corp	III	Feb-03-2012
6	Integra LifeSciences Corp.	II	Mar-03-2011
7	Integra LifeSciences Corp.	II	Oct-28-2010
8	Integra LifeSciences Corp.	II	Apr-20-2010