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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 VISION FAMILY OF CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS016
Date Received10/26/2009
Decision Date11/24/2009
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to optimize the vision stent laser cutting process to reduce stent (strut) dimensional variation and improve overall process capability.
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