PMA P990037S001

Device: DIAGNOSTIC DUETT
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S001
Product code: MGB
Decision date: 2001-11-02
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR THE CHANGE IN DILUENT AND PROCOAGULANT COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIAGNOSTIC DUETT AND IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.

Current openFDA PMA Record#

Device: DIAGNOSTIC DUETT
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S001
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2001-11-02
Decision code: APPR
Date received: 2000-10-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CHANGE IN DILUENT AND PROCOAGULANT COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIAGNOSTIC DUETT AND IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.