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
ApplicantBARD PERIPHERAL VASCULAR, INC.
Date Received2021-02-25
Decision Date2021-03-23
PMAP130029
SupplementS009
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
S005
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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