TPLC - Total Product Life Cycle

Device	retractor
Regulation Description	Manual surgical instrument for general use.
Product Code	GAD
Regulation Number	878.4800
Device Class	1

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	2
ADEPT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
APPLE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
EZSURGICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDIN CORP.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
SCHOLTEN SURGICAL INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
T. KOROS SURGICAL
	SUBSTANTIALLY EQUIVALENT	8
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	16
Fracture	10
Tears, rips, holes in device, device material	4
Other (for use when an appropriate device code cannot be identified)	4
Detachment of device component	3
Device maintenance issue	2
Overheating of device or device component	2
Replace	2
Material separation	2
Air leak	1
Material rupture	1
Peeled	1
Difficult to remove	1
Unintended system motion	1
Difficult to insert	1
Leak	1
Crack	1
Degraded	1
Component(s), broken	1
Unknown (for use when the device problem is not known)	1
Component missing	1
Device Issue	1
Malfunction	1
No Known Device Problem	1
Device handling issue	1
Total Device Problems	61