TPLC - Total Product Life Cycle

Device	suture, absorbable, synthetic, polyglycolic acid
Regulation Description	Absorbable poly(glycolide/l-lactide) surgical suture.
Product Code	GAM
Regulation Number	878.4493
Device Class	2

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	5
ARC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
COAPT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	4
DEMETECH CORP.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ETHICON
	SUBSTANTIALLY EQUIVALENT	13
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
GENZYME CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	3
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MANI, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MITEK
	SUBSTANTIALLY EQUIVALENT	1
NEAT STITCH LTD.
	SUBSTANTIALLY EQUIVALENT	1
PETERS SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
SAMYANG CORP.
	SUBSTANTIALLY EQUIVALENT	1
SERRAL, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL SPECIALTIES CORP.
	SUBSTANTIALLY EQUIVALENT	4
SUTURES INDIA PVT., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
TYCO HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
UNITED MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	4
VISIONARY MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Break	720
Other (for use when an appropriate device code cannot be identified)	622
Reaction	222
Needle, separation	210
Absorption	37
Unknown (for use when the device problem is not known)	27
Device remains implanted	7
Implant extrusion	4
Tip breakage	4
Material perforation	3
Detachment of device or device component	1
Tear, rip or hole in device packaging	1
Device, removal of (non-implant)	1
Detachment of device component	1
Kinked	1
Total Device Problems	1861