PMA P990037S014

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S014
Product code: MGB
Decision date: 2003-03-14
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR AN ADDITIONAL INCOMING INSPECTION REQUIREMENT TO MEASURE THE OUTER DIAMETER (OD) OF THE DISTAL END OF THE STOPCOCK AND TO TIGHTEN THE TOLERANCE AROUND THE ORIGINALLY APPROVED OD ON THE STOPCOCK DISTAL END.

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S014
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-03-14
Decision code: APPR
Date received: 2003-02-24
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ADDITIONAL INCOMING INSPECTION REQUIREMENT TO MEASURE THE OUTER DIAMETER (OD) OF THE DISTAL END OF THE STOPCOCK AND TO TIGHTEN THE TOLERANCE AROUND THE ORIGINALLY APPROVED OD ON THE STOPCOCK DISTAL END.