|
Device | PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEMS |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S063 |
Date Received | 04/16/2008 |
Decision Date | 06/12/2008 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING FROM THE SURGIPRO II SUTURE TO THE MODIFIED SURGIPRO II SUTURE. |