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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 WEST 3RD ST.
TEMPE, AZ 85281-1740
PMA NumberP160024
Supplement NumberS005
Date Received07/13/2018
Decision Date08/09/2018
Product Code PRL 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modifications to your testing plan following real time aging.
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