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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.
 
DeviceLifeStream Balloon Expandable Vascular Covered Stent
Generic NameIliac covered stent, arterial
ApplicantBard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe, AZ 85281
PMA NumberP160024
Supplement NumberS007
Date Received06/27/2019
Decision Date09/09/2019
Product Code PRL 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the LifeStream Balloon Expandable Vascular Covered Stent labeling to incorporate the 3-year results of the BOLSTER Clinical Study.
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