PMA P040044S062

Device: MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE)
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S062
Product code: MGB
Decision date: 2015-03-03
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR MINOR MODIFICATIONS TO THE MYNX ACE DEVICE THAT INVOLVE BUTTON 3, THE PACKAGING TRAY, AND INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH BUTTON 3.

Current openFDA PMA Record#

Device: MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE)
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S062
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2015-03-03
Decision code: APPR
Date received: 2014-12-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MINOR MODIFICATIONS TO THE MYNX ACE DEVICE THAT INVOLVE BUTTON 3, THE PACKAGING TRAY, AND INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH BUTTON 3.