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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMULTI-LINK RX/OTW VISION CORONARY STENT SYSTEMS ARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Date Received10/21/2002
Decision Date07/16/2003
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 03M-0499
Notice Date 11/04/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the multi-link rx and otw vision coronary stent systems (css). These devices are indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <25 mm) with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm. 2) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <25 mm) with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm 3) restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by st segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length <25 mm with a reference vessel diameter of 3. 0 mm to 4. 0 mm. Outcome (beyond 9 months) for this permanent implant is unknown at present.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
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S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 
S044 S046 S047 S048 S049 S050 
S051 S052 S053 
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