PMA P990037S021

Device: DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S021
Product code: MGB
Decision date: 2004-07-14
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE.

Current openFDA PMA Record#

Device: DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S021
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2004-07-14
Decision code: APPR
Date received: 2004-06-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE.