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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.
 
DeviceVisi-Pro™ Balloon-Expandable Peripheral Stent System, lntraStent™ DoubleStrut™ Stent
Generic NameSTENT, ILIAC
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP030045
Supplement NumberS009
Date Received03/07/2024
Decision Date04/05/2024
Product Code NIO 
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  
a new sterilization cycle with reduced EO concentration using chamber 71 at the contract sterilizer
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