LifeStream® Balloon Expandable Vascular Covered Stent

FDA Premarket Approval P160024 S012

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

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 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
Date Received2022-02-24
Decision Date2022-08-23
PMAP160024
SupplementS012
Product CodePRL 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBARD PERIPHERAL VASCULAR, INC.
1625 West 3rd St.
tempe, AZ 85281-1740 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 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

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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