Bard Fluency Plus Endovascular Stent Graft

FDA Premarket Approval P130029 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

The addition of a new laser for welding radiopaque markers to the stent

DeviceBard Fluency Plus Endovascular Stent Graft
Generic NameSystem, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
Date Received2021-02-25
Decision Date2021-03-23
Product CodePFV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281

Supplemental Filings

Supplement NumberDateSupplement Type
P130029Original Filing
S009 2021-02-25 30-day Notice
S008 2020-05-01 30-day Notice
S007 2017-04-10 Normal 180 Day Track No User Fee
S006 2016-11-30 135 Review Track For 30-day Notice
S004 2016-02-12 Normal 180 Day Track No User Fee
S003 2015-06-15 Special (immediate Track)
S002 2015-05-01 Panel Track
S001 2015-04-08 135 Review Track For 30-day Notice

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