|
Device | MYNX VASCULAR CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S003 |
Date Received | 10/05/2007 |
Decision Date | 11/14/2007 |
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 USE OF UV/ CYANOACRYLATE ADHESIVE FOR THE BALLOON PROXIMAL BOND AND USE OF BALLOON BLOWING AND TUBING NECKER MACHINES. |