LifeStream Balloon Expandable Vascular Covered Stent

Iliac Covered Stent, Arterial

FDA Premarket Approval P160024 S005

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

Modifications to your testing plan following real time aging.

DeviceLifeStream Balloon Expandable Vascular Covered Stent
Classification NameIliac Covered Stent, Arterial
Generic NameIliac Covered Stent, Arterial
ApplicantBARD PERIPHERAL VASCULAR, INC.
Date Received2018-07-13
Decision Date2018-08-09
PMAP160024
SupplementS005
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
S012 2022-02-24 Normal 180 Day Track No User Fee
S011 2021-09-30 Real-time Process
S010 2020-09-28 30-day Notice
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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