PMA P040044S054

Device: MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY)
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S054
Product code: MGB
Decision date: 2014-06-18
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR DESIGN AND MANUFACTURING PROCESS CHANGES TO THE O-RING COMPONENT FOR THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.

Current openFDA PMA Record#

Device: MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY)
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S054
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2014-06-18
Decision code: APPR
Date received: 2014-04-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN AND MANUFACTURING PROCESS CHANGES TO THE O-RING COMPONENT FOR THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.