|
Device | PERCLOSE PROGLIDE 6FR 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 | S053 |
Date Received | 03/15/2004 |
Decision Date | 04/22/2004 |
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 REVISED INSTRUCTIONS FOR USE, INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE. |