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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 VISION CORONARY STENT SYSTEM - 2.75 MM
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR
P.O. BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP020047
Supplement NumberS004
Date Received05/17/2004
Decision Date09/10/2004
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE 2.75 MM LINE EXTENSION FOR THE MULTI-LINK VISION CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.75 MM.
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