PMA P040044S080
- Device
- MynxGrip, Mynx Ace Vascular Closure Device (VCD)
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S080
- Product code
- MGB
- Decision date
- 2018-04-27
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Implementation of an in-process shelf life for the hydrogel component.
Current openFDA PMA Record#
- Device
- MynxGrip, Mynx Ace Vascular Closure Device (VCD)
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S080
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-04-27
- Decision code
- OK30
- Date received
- 2018-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an in-process shelf life for the hydrogel component.