|
Device | PERCLOSE A-T AND 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 | S054 |
Date Received | 07/02/2004 |
Decision Date | 07/15/2004 |
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 MODIFIED SHEATH AND FOOT ASSEMBLIES ON THE PERCLOSE A-T AND PROGLIDE DEVICES AND THE ADDITION OF A SUTURE CUTTER ON THE PERCLOSE A-T DEVICE. |