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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.
Classification Namestent, coronary
Generic Namestent, coronary
p.o. box 9018
temecula, CA 92589-9018
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
Recalls CDRH Recalls
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 
S057 S058 S059 S060 S061 S063