PMA P990037S010

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S010
Product code: MGB
Decision date: 2002-04-30
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR CHANGING THE SUPPLIER FROM COOK PHARMACEUTICALS TO CHESAPEAKE BIOLOGICAL LABORATORIES. THIS CHANGE WILL ALSO AFFECT THE APPROVED DILUENT. SPECIFICALLY, THE CURRENT APPROVED BUFFERING AGENT COMPONENT, 0.1% TROLAMINE NF (TEA) WILL BE CHANGED TO 0.1% TROMETHAMINE USP (TRIS).

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S010
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2002-04-30
Decision code: APPR
Date received: 2002-02-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGING THE SUPPLIER FROM COOK PHARMACEUTICALS TO CHESAPEAKE BIOLOGICAL LABORATORIES. THIS CHANGE WILL ALSO AFFECT THE APPROVED DILUENT. SPECIFICALLY, THE CURRENT APPROVED BUFFERING AGENT COMPONENT, 0.1% TROLAMINE NF (TEA) WILL BE CHANGED TO 0.1% TROMETHAMINE USP (TRIS).