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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 8 SMALL VESSEL CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR
p.o. box 9018
temecula, CA 92589-9018
PMA NumberP020047
Supplement NumberS022
Date Received07/01/2010
Decision Date08/31/2010
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE 2.25MM DIAMETER STENT SIZE AS PART OF THE MULTI-LINK 8 CORONARY STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MULTI-LINK 8 SV CORONARY STENT SYSTEM AND IS INDICATED FOR 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 2.25MM.
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