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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 DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS011
Date Received02/26/1999
Decision Date05/06/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a 5-year post-approval study protocol for the acs multi-link rx and otw duet(tm) coronary stent systems.
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