|
Device | PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S082 |
Date Received | 07/01/2013 |
Decision Date | 08/29/2013 |
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 A CHANGE TO THE BACKDOWN DETENT (BDD) FORCESPECIFICATION FOR THE PROSTAR XL® PVS SYSTEM. |