|Trade Name||MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM|
|Classification Name||stent, coronary|
|Generic Name||coronary stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the 2. 75 mm line extension for the multi-link vision coronary stent system. The device is indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length <=25 mm) with reference vessel diameters of 2. 75 mm.