PMA P040044S073
- Device
- MYNX ACE VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S073
- Product code
- MGB
- Decision date
- 2016-07-06
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Add a second sterilization line at a previously approved alternate sterilization facility (Synergy Health in San Diego, California).
Current openFDA PMA Record#
- Device
- MYNX ACE VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S073
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-07-06
- Decision code
- OK30
- Date received
- 2016-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a second sterilization line at a previously approved alternate sterilization facility (Synergy Health in San Diego, California).