PMA P050038S004

Device: ARISTA AH ABSORBABLE HEMOSTAT
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S004
Product code: LMG
Decision date: 2008-01-14
Classification: Agent, Absorbable Hemostatic, Non-collagen Based
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ENPATH MEDICAL, INC., MINNEAPOLIS, MINNESOTA TO PERFORM FILLING, PACKAGING, AND LABELING OF THE DEVICE.

Current openFDA PMA Record#

Device: ARISTA AH ABSORBABLE HEMOSTAT
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S004
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2008-01-14
Decision code: APPR
Date received: 2007-11-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ENPATH MEDICAL, INC., MINNEAPOLIS, MINNESOTA TO PERFORM FILLING, PACKAGING, AND LABELING OF THE DEVICE.