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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 DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS031
Date Received04/11/2001
Decision Date06/05/2001
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 a new indication for the acs multi-link rx and otw d, tristar, ultr tetra coronary stent systems and acs multi-link. Stent and the four delivery systems. The new additional indication for these devices is for use in patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length = 25 mm) with a reference vessel diameter of 3. 0 mm to 4. 0 mm.
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