PMA P040044S075
- Device
- MYNXGRIP VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S075
- Product code
- MGB
- Decision date
- 2017-06-28
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to implement process improvements for the balloon to catheter bonds.
Current openFDA PMA Record#
- Device
- MYNXGRIP VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S075
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2017-06-28
- Decision code
- APPR
- Date received
- 2016-11-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement process improvements for the balloon to catheter bonds.