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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 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS043
Date Received02/19/2003
Decision Date07/22/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the post-approval requirement period from 5 to 4 years and to update the labeling with clinical data from 4 year follow-up.
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