|
Device | MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S069 |
Date Received | 01/05/2016 |
Decision Date | 01/31/2016 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TO SOURCE POLYETHYLENE GLYCOL (PEG) RAW MATERIALS USED IN THE HYDROGEL SEALANT OF MYNX DEVICES FROM AN ALTERNATE MANUFACTURING FACILITY. |