TPLC - Total Product Life Cycle

• Device: pack, hot or cold, disposable
• Regulation Description: Hot or cold disposable pack.
• Product Code: IMD
• Regulation Number: 890.5710
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
BIO-LIPID, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORP.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	3
DEROYAL
	SUBSTANTIALLY EQUIVALENT	1
GAYMAR INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	3
OMNI
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
PRISM
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
SPENCO
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Known Device Problem	19
Other (for use when an appropriate device code cannot be identified)	9
Nonstandard device or device component	6
No Information	5
Unknown (for use when the device problem is not known)	2
Fluid leak	2
Device operates differently than expected	2
Heat	1
Heat, failure to	1
Premature system activation	1
Use of Device Issue	1
Defective item	1
Leak	1
Total Device Problems	51

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Sep-26-2008
2	Chattem Inc	II	Mar-08-2008
3	Pfizer Global	II	Dec-16-2010