PMA P040044S078
- Device
- MynxGrip and Mynx Ace Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S078
- Product code
- MGB
- Decision date
- 2018-11-16
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to add a new vendor for the hydrogel sealant components and to extend the shelf life of the hydrogel component to 25 months.
Current openFDA PMA Record#
- Device
- MynxGrip and Mynx Ace Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S078
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-11-16
- Decision code
- APPR
- Date received
- 2017-11-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add a new vendor for the hydrogel sealant components and to extend the shelf life of the hydrogel component to 25 months.