PMA P990037S008

Device: VASCULAR SOLUTION DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S008
Product code: MGB
Decision date: 2002-05-29
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DELIVERY CANNULAE AND THE PROCOAGULANT AND CHANGING THE BUFFERING AGENT IN THE DILUTENT TO TROMETHAMINE USP (TRIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DUETT FLOWABLE HEMOSTAT DEVICE AND IS INDICATED FOR USE AS ADJUNCT TREATMENT IN OBTAINING HEMOSTASIS IN SEALING RESIDUAL OOZING OF TISSUE TRACTS OF FEMORAL ACCESS SITES THAT HAVE BEEN PREVIOUSLY CLOSED BY SUTURE MEDIATED/COLLAGEN-BASED HEMOSTATIC DEVICES.

Current openFDA PMA Record#

Device: VASCULAR SOLUTION DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S008
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2002-05-29
Decision code: APPR
Date received: 2001-12-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DELIVERY CANNULAE AND THE PROCOAGULANT AND CHANGING THE BUFFERING AGENT IN THE DILUTENT TO TROMETHAMINE USP (TRIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DUETT FLOWABLE HEMOSTAT DEVICE AND IS INDICATED FOR USE AS ADJUNCT TREATMENT IN OBTAINING HEMOSTASIS IN SEALING RESIDUAL OOZING OF TISSUE TRACTS OF FEMORAL ACCESS SITES THAT HAVE BEEN PREVIOUSLY CLOSED BY SUTURE MEDIATED/COLLAGEN-BASED HEMOSTATIC DEVICES.