|Trade Name||VASOSEAL 4-5 FRENCH SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Generic Name||vascular hemostasis device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to market a smaller version of the vasoseal vhd device. The device, as modified, will be marketed under the trade name vasoseal 4-5 french system and is indicated for "use in sealing the femoral arterial puncture site in patients who have undergone diagnostic catheterization procedures using a 4 or 5 french procedural sheath and using a retrograde approach. The vasoseal 4-5 french system reduces time to hemostasis, ambulation and discharge in patients who have undergone diagnostic catheterization procedures. ".