|Trade Name||SUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| 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.