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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 NumberS012
Date Received02/24/2022
Decision Date08/23/2022
Product Code PRL 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, Karlsruhe Baden-Wurttemberg 76227, Germany for supplying the bare metal stent component.
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