|Trade Name||ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS|
|Classification Name||stent, coronary|
|Generic Name||intravascular coronary stent|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the acs multi-link coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 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 diameters from 2. 0 to 2. 5 mm. Long term outcome for this permanent implant is unknown at present.