|
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 | S004 |
Date Received | 11/16/2007 |
Decision Date | 12/17/2007 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING AND TESTING PROCESS FOR THE DEVICE. |