|Trade Name||MULTI-LINK RX TETRA/OTW TETRA CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||coronary stent system|
|Applicant||ABBOTT VASCULAR-CARDIAC THERAPIES|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for inclusion of six-month trial data in the instructions for use booklet for the multi-link rx and otw tetra coronary stent systems. The multi-link rx and otw tetra coronary stent systems are indicated for improving coronary luminal 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 reference vessel diameters of 3. 0 mm to 4. 0 mm; 2) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <= 35 mm) with reference vessel diameters ranging from 3. 0 to 4. 0 mm; and 3) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference vessel diameters ranging from 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 are solely indicated for use in patients with abrupt or threatened abrupt closure. The 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure and patients with lesions in saphenous vein bypass grafts.