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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMULTI-LINK CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Supplement NumberS046
Date Received01/27/2005
Decision Date04/21/2005
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO UPDATE THE IFU TO REVISE THE MRI STATEMENT.
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