TPLC - Total Product Life Cycle

Device	catheter, peripheral, atherectomy
Regulation Description	Intraluminal artery stripper.
Product Code	MCW
Regulation Number	870.4875
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	2
BACCHUS VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	3
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	3
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIO SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIOVASCULAR SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	10
DOW
	SUBSTANTIALLY EQUIVALENT	2
EV3 CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
FOXHOLLOW TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	6
IDEV TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
KENSEY NASH CORP.
	SUBSTANTIALLY EQUIVALENT	2
MEDRAD, INC.
	SUBSTANTIALLY EQUIVALENT	2
MICRO THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MICROVENA
	SUBSTANTIALLY EQUIVALENT	3
PATHWAY MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	16
POSSIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRANETICS CORP.
	SUBSTANTIALLY EQUIVALENT	8

Device Problems
No Known Device Problem	165
Break	7
Material separation	6
Detachment of device or device component	6
Material fragmentation	5
Entrapment of device or device component	4
Difficult to remove	3
Shipping damage or problem	3
Tear, rip or hole in device packaging	2
Detachment of device component	2
Decoupling	2
Component(s), broken	1
Fracture	1
Failure to advance	1
Defective item	1
Blockage within device or device component	1
Stretched	1
Improper or incorrect procedure or method	1
Other (for use when an appropriate device code cannot be identified)	1
Unknown (for use when the device problem is not known)	1
Wire(s), breakage of	1
Total Device Problems	215