LifeStream Balloon Expandable Vascular Covered Stent

FDA Premarket Approval P160024 S009

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.

Pre-market Approval Supplement Details

To implement an optimized laser process for a bond on the balloon catheter

DeviceLifeStream Balloon Expandable Vascular Covered Stent
Generic NameIliac Covered Stent, Arterial
ApplicantBARD PERIPHERAL VASCULAR, INC.
Date Received2020-08-28
Decision Date2020-09-24
PMAP160024
SupplementS009
Product CodePRL 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BARD PERIPHERAL VASCULAR, INC. 1625 West 3rd St. tempe, AZ 85281-1740

Supplemental Filings

Supplement NumberDateSupplement Type
P160024Original Filing
S009 2020-08-28 30-day Notice
S008 2020-04-21 30-day Notice
S007 2019-06-27 Normal 180 Day Track No User Fee
S006 2018-11-28 30-day Notice
S005 2018-07-13 30-day Notice
S004 2018-03-23 30-day Notice
S003 2018-03-16 135 Review Track For 30-day Notice
S002 2017-09-27 Real-time Process
S001 2017-06-19 30-day Notice

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