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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 NameMULTI-LINK CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR INC.
PMA NumberP970020
Supplement NumberS047
Date Received06/12/2006
Decision Date07/13/2006
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications for the ifus to include additional information regarding the material components of the stents.
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