|
Device | PERCLOSE A-T 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S042 |
Date Received | 10/08/2002 |
Decision Date | 11/12/2002 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXPANDING THE INDICATIONS FOR USE OF THE CLOSER A-T 6 FR. SMC SYSTEM TO INCLUDE 7 AND 8 FR. SHEATH SIZES AND TO CHANGE THE LABELING TO INCLUDE <0.038" GUIDEWIRES. |