- Device
- MynxGrip Vascular Closure Device (SF, 6F/7F) ; Mynx Control Vascular Closure Device (SF, 6F/7F)
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S089
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-11-10
- Decision code
- OK30
- Date received
- 2021-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate method for cutting the hydrogel sealant used in the Mynx Vascular Closure Device product family.