|Trade Name||MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||intravascular coronary stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the acs multi-link rx and otw tetra(tm) coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with a reference vessel diameter of 3. 0 mm to 4. 0 mm; and 2) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference diameters in the range of 2. 5 mm to 4. 0 mm. Long term outcome for this permanent implant is unknown at present. Note: the 2. 5 mm and 2. 75 mm diameter stents and the 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure.