|
Device | EXOSEAL VASCULAR CLOSURE DEVICE (VCD) |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P100013 |
Supplement Number | S010 |
Date Received | 03/24/2014 |
Decision Date | 04/23/2014 |
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 BRING MANUFACTURING OF AN INJECTION MOLDED COMPONENT IN-HOUSE AND REPLACE THE SINGLE- WITH THE MULTI-CAVITY MOLDING PROCESS. |