PMA P040044S060
- Device
- MYNX ACE VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S060
- Product code
- MGB
- Decision date
- 2015-01-09
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- IMPLEMENT A REWORK STEP TO RELOAD THE HYDROGEL IN THE MYNX ACE DEVICE (MODEL MX6740).
Current openFDA PMA Record#
- Device
- MYNX ACE VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S060
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2015-01-09
- Decision code
- OK30
- Date received
- 2014-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENT A REWORK STEP TO RELOAD THE HYDROGEL IN THE MYNX ACE DEVICE (MODEL MX6740).