PMA P040044S069
- Device
- MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S069
- Product code
- MGB
- Decision date
- 2016-01-31
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- TO SOURCE POLYETHYLENE GLYCOL (PEG) RAW MATERIALS USED IN THE HYDROGEL SEALANT OF MYNX DEVICES FROM AN ALTERNATE MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
- Applicant
- Cordis US Corporation
- PMA number
- P040044
- Supplement
- S069
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-01-31
- Decision code
- OK30
- Date received
- 2016-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO SOURCE POLYETHYLENE GLYCOL (PEG) RAW MATERIALS USED IN THE HYDROGEL SEALANT OF MYNX DEVICES FROM AN ALTERNATE MANUFACTURING FACILITY.