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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 NameMULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP970020
Supplement NumberS038
Date Received11/23/2001
Decision Date05/22/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product 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 penta coronary stent systems. The multi-link rx and otw penta 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.
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