|
Device | 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 | S014 |
Date Received | 04/11/2017 |
Decision Date | 08/07/2017 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of Cordis Corporation, Miami Lakes, Florida as an alternate supplier for the Delivery Shaft component of the 6F EXOSEAL Vascular Closure Device. |