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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 DUET & TRISTAR CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS020
Date Received02/23/2000
Decision Date03/20/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested changes to the electropolishing parameters of the stent. The reason for the change is to opitmize the efficiency of the electropolishing process.
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