PMA P990037S009

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S009
Product code: MGB
Decision date: 2002-04-03
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO THE DUETT SEALING DEVICE AND DIAGNOSTIC DUETT SEALING DEVICE. SPECIFICALLY, A RELIEF VALVE COMPONENT WILL REPLACE THE PILOT BALLOON ASSEMBLY ON BOTH DEVICES.

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S009
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2002-04-03
Decision code: APPR
Date received: 2002-03-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO THE DUETT SEALING DEVICE AND DIAGNOSTIC DUETT SEALING DEVICE. SPECIFICALLY, A RELIEF VALVE COMPONENT WILL REPLACE THE PILOT BALLOON ASSEMBLY ON BOTH DEVICES.