- Device
- MynxGrip Vascular Closure Device (5F, 6F/7F); Mynx Control Vascular Closure Device (5F, 6F/7F); Mynx Control Venous Vasc
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S110
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2025-07-23
- Decision code
- OK30
- Date received
- 2025-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- conducting routine Bioburden testing at an alternate, in-house test site