PMA P050038S007

Device: ARISTA AH ABSORBABLE HEMOSTAT
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S007
Product code: LMG
Decision date: 2008-07-02
Classification: Agent, Absorbable Hemostatic, Non-collagen Based
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITASURE AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIAL BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

Current openFDA PMA Record#

Device: ARISTA AH ABSORBABLE HEMOSTAT
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S007
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2008-07-02
Decision code: APPR
Date received: 2008-06-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITASURE AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIAL BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.