PMA P990037S019

Device: DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S019
Product code: MGB
Decision date: 2003-06-13
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A SHELF-LIFE EXTENSION OF THE TRIS DILUENT COMPONENT, FOR THE DEVICES LISTED ABOVE, FROM THE APPROVED 24 MONTHS TO 36 MONTHS.

Current openFDA PMA Record#

Device: DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S019
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-06-13
Decision code: APPR
Date received: 2003-05-16
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A SHELF-LIFE EXTENSION OF THE TRIS DILUENT COMPONENT, FOR THE DEVICES LISTED ABOVE, FROM THE APPROVED 24 MONTHS TO 36 MONTHS.