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Device | SUTURE TRIMMER FOR THE CLOSER II 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 | S043 |
Date Received | 11/18/2002 |
Decision Date | 12/20/2002 |
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 DESIGN CHANGES TO THE SUTURE TRIMMER (ST). SPECIFICALLY THE ST WAS MODIFIED TO OPERATE BY SLIDING RATHER THAN BY CLEAVING THE SUTURE BY CUTTING SURFACE ROTATION. |