PMA P040044S111
- Device
- Mynx Control Vascular Closure Device (5F, 6F/7F)
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S111
- Product code
- MGB
- Decision date
- 2026-03-31
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- to decrease the minimum E-beam irradiation sterilization dose for the Mynx Control Vascular Closure Device
Current openFDA PMA Record#
- Device
- Mynx Control Vascular Closure Device (5F, 6F/7F)
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S111
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-03-31
- Decision code
- OK30
- Date received
- 2026-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to decrease the minimum E-beam irradiation sterilization dose for the Mynx Control Vascular Closure Device