PMA P040044S084
- Device
- Mynx CONTROL Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S084
- Product code
- MGB
- Decision date
- 2019-06-21
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Utilize an alternative sterilization site already approved under this PMA for sterilization of the Mynx CONTROL vascular closure device.
Current openFDA PMA Record#
- Device
- Mynx CONTROL Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S084
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-06-21
- Decision code
- OK30
- Date received
- 2019-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Utilize an alternative sterilization site already approved under this PMA for sterilization of the Mynx CONTROL vascular closure device.