|
Device | Cordis Exoseal Vascular Closure Device |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P100013 |
Supplement Number | S015 |
Date Received | 08/11/2017 |
Decision Date | 12/14/2017 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to add Steri-Tek as a new E-beam sterilization site for the Exoseal Vascular Closure Device. |