PMA P150006S001

Device: CELT ACD VASCULAR CLOSURE DEVICE
Applicant: Vasorum, Ltd.
PMA number: P150006
Supplement: S001
Product code: MGB
Decision date: 2017-06-27
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Approval for the addition of a 7F size CELT ACD Vascular Closure Device and minor manufacturing and design changes to the 5F, 6F, and 7F CELT ACD Vascular Closure Devices.

Current openFDA PMA Record#

Device: CELT ACD VASCULAR CLOSURE DEVICE
Applicant: Vasorum, Ltd.
PMA number: P150006
Supplement: S001
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2017-06-27
Decision code: APPR
Date received: 2016-10-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a 7F size CELT ACD Vascular Closure Device and minor manufacturing and design changes to the 5F, 6F, and 7F CELT ACD Vascular Closure Devices.