PMA P990037S007

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S007
Product code: MGB
Decision date: 2001-12-31
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT STRATIFIES ADVERSE EVENTS INTO DIAGNOSTIC AND INTERVENTIONAL PATIENT POPULATIONS.

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S007
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2001-12-31
Decision code: APPR
Date received: 2001-11-28
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT STRATIFIES ADVERSE EVENTS INTO DIAGNOSTIC AND INTERVENTIONAL PATIENT POPULATIONS.