PMA P050007S006

Device: STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM
Applicant: Abbott Vascular Devices
PMA number: P050007
Supplement: S006
Product code: MGB
Decision date: 2007-07-30
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR DESIGN CHANGES TO THE PUSHER BODY FOR BOTH THE STARCLOSE? VASCULAR CLOSURE SYSTEM (VCS) AND THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM AD FOR THE ADDITION OF CHAMBERS ON THE INTERIOR OF THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM TO IMPROVE THE RETRACTION OF THE THUMB ADVANCER.

Current openFDA PMA Record#

Device: STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM
Applicant: Abbott Vascular Devices
PMA number: P050007
Supplement: S006
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2007-07-30
Decision code: APPR
Date received: 2007-05-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN CHANGES TO THE PUSHER BODY FOR BOTH THE STARCLOSE? VASCULAR CLOSURE SYSTEM (VCS) AND THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM AD FOR THE ADDITION OF CHAMBERS ON THE INTERIOR OF THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM TO IMPROVE THE RETRACTION OF THE THUMB ADVANCER.