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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 AND OTW DUET CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS014
Date Received04/16/1999
Decision Date05/14/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in the manufacturing operation for the stent systems packaging.
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