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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/MINI VISION FAMILY OF CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular
P.O. Box 9018
Temecula, CA 92589
PMA NumberP020047
Supplement NumberS021
Date Received06/23/2010
Decision Date07/20/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INCREASE IN THE MINIMUM SEAL LENGTH REQUIREMENT FOR THE MANUFACTURING OF THE STENT DELIVERY SYSTEM.
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