|
Device | PERCLOSE A-T SUTURE MEDIATED CLOSURE(SMC) SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S059 |
Date Received | 07/06/2006 |
Decision Date | 08/08/2006 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) FOR THE PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM. |