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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP970020
Supplement NumberS035
Date Received08/06/2001
Decision Date01/14/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an indication to use the 4. 5 mm and 5. 0 mm ultra otw and rx for the treatment of saphenous vein graft (svg) lesions. The multi-link rx ultra and multi-link otw ultra coronary stent system will include the following indication: 1) patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <=25 mm) with reference vessel eiameters ranging from 3. 5 mm to 5. 0 mm; 2) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <=35) with reference vessel diameters ranging from 3. 5 mm to 5. 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 diameters in the range of 3. 5 mm to 5. 0 mm. Long term outcome for this permanent implant is unknown at present. Note: the 38 mm lentgh stents are solely indicated for use in patients with abrupt or threatened abrupt closure and patients with lesions in saphenous vein bypass grafts.
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