TPLC - Total Product Life Cycle

• Device: suture, surgical, absorbable, polydioxanone
• Regulation Description: Absorbable polydioxanone surgical suture.
• Product Code: NEW
• Regulation Number: 878.4840
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
ANGIOTECH
	SUBSTANTIALLY EQUIVALENT	2
ARC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST MANUFACTURING US LLC
	SUBSTANTIALLY EQUIVALENT	1
DEMETECH CORP.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ETHICON
	SUBSTANTIALLY EQUIVALENT	2
FOOSIN MEDICAL SUPPLIES INC.
	SUBSTANTIALLY EQUIVALENT	1
GENZYME CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
LSI SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
QUILL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL SPECIALTIES CORP.
	SUBSTANTIALLY EQUIVALENT	5
SUTURES INDIA PVT., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNILENE S.A.C.
	SUBSTANTIALLY EQUIVALENT	1
UNITED MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	104
Other (for use when an appropriate device code cannot be identified)	35
Needle, separation	13
Reaction	8
Unknown (for use when the device problem is not known)	4
Component(s), broken	3
Device remains implanted	1
Tip breakage	1
Total Device Problems	169

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

Recalls
Manufacturer		Recall Class	Date Posted
1	C P Medical	II	Sep-27-2010
2	C P Medical Inc.	II	Nov-19-2011
3	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Apr-25-2013
4	Ethicon, Inc.	II	May-12-2009