|Trade Name||X-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Generic Name||vascular hemostasis device|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new accessory that incorporates the knot pusher and suture cutter accessories into a single device. This newly created accessory will be marketed under the trade name x-press trimmer, which allows the operator to push the clinch knot and cut the suture below the skin line following the use of the x-press 6 french vascular closure system.