PMA P040044S057

Device: MYNX ACE VASCULAR CLOSURE DEVICE
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S057
Product code: MGB
Decision date: 2014-08-18
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A MODIFIED PACKAGING TRAY, REMOVAL OF THE GUIDEWIRE AND J-STRAIGHTENER, AND UPDATED IFU TO REMOVE REFERENCES TO THE PROVIDED GUIDEWIRE AND J-STRAIGHTENER.

Current openFDA PMA Record#

Device: MYNX ACE VASCULAR CLOSURE DEVICE
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S057
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2014-08-18
Decision code: APPR
Date received: 2014-05-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED PACKAGING TRAY, REMOVAL OF THE GUIDEWIRE AND J-STRAIGHTENER, AND UPDATED IFU TO REMOVE REFERENCES TO THE PROVIDED GUIDEWIRE AND J-STRAIGHTENER.