FLAIR ENDOVASCULAR STENT GRAFT

System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment

FDA Premarket Approval P060002

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the flair endovascular stent graft. The device is indicated for use in the treatment of stenoses at the venous anastomosis of eptfe or other synthetic arteriovenous (av) access grafts.

DeviceFLAIR ENDOVASCULAR STENT GRAFT
Classification NameSystem, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
Generic NameSystem, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
ApplicantBARD PERIPHERAL VASCULAR
Date Received2006-01-17
Decision Date2007-07-23
Notice Date2007-08-01
PMAP060002
SupplementS
Product CodePFV
Docket Number07M-0298
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BARD PERIPHERAL VASCULAR 1625 W. Third St tempe, AZ 85281
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P060002Original Filing
S040 2018-03-16 135 Review Track For 30-day Notice
S039 2017-06-19 30-day Notice
S038 2016-11-30 135 Review Track For 30-day Notice
S037
S036 2015-04-08 135 Review Track For 30-day Notice
S035 2014-03-24 30-day Notice
S034 2014-02-14 Normal 180 Day Track No User Fee
S033 2013-08-21 30-day Notice
S032 2013-05-09 30-day Notice
S031 2013-04-05 30-day Notice
S030 2013-03-29 30-day Notice
S029 2013-02-19 30-day Notice
S028 2012-09-27 Special (immediate Track)
S027 2012-07-19 Normal 180 Day Track
S026 2012-05-21 30-day Notice
S025 2012-04-02 30-day Notice
S024 2012-02-01 135 Review Track For 30-day Notice
S023
S022 2011-10-28 30-day Notice
S021 2011-10-21 30-day Notice
S020 2011-08-26 30-day Notice
S019
S018
S017 2011-01-20 30-day Notice
S016 2010-08-10 30-day Notice
S015 2010-08-10 30-day Notice
S014 2010-07-28 30-day Notice
S013 2010-07-20 30-day Notice
S012
S011 2010-03-19 Special (immediate Track)
S010 2010-03-19 135 Review Track For 30-day Notice
S009 2009-11-19 30-day Notice
S008 2009-11-18 30-day Notice
S007 2009-11-05 30-day Notice
S006 2009-09-30 Normal 180 Day Track No User Fee
S005 2009-07-22 Normal 180 Day Track No User Fee
S004 2009-02-02 30-day Notice
S003 2008-08-29 Special (immediate Track)
S002 2008-03-20 Normal 180 Day Track
S001 2007-08-22 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
04049519009032 P060002 000
04049519008868 P060002 000
04049519008851 P060002 000
04049519008844 P060002 000
04049519008837 P060002 000
04049519008820 P060002 000
04049519008813 P060002 000
04049519008806 P060002 000
04049519008790 P060002 000
04049519008783 P060002 000
04049519008776 P060002 000
04049519008769 P060002 000
04049519008752 P060002 000
04049519008745 P060002 000
04049519008875 P060002 000
04049519008899 P060002 000
04049519009025 P060002 000
04049519009018 P060002 000
04049519009001 P060002 000
04049519008998 P060002 000
04049519008981 P060002 000
04049519008974 P060002 000
04049519008967 P060002 000
04049519008950 P060002 000
04049519008943 P060002 000
04049519008936 P060002 000
04049519008929 P060002 000
04049519008912 P060002 000
04049519008905 P060002 000
04049519008738 P060002 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.