OVATION ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P120006

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 ovation abdominal stent graft system. This device is indicated for treatment of patients with abdominalaortic aneurysms having vascular morphology suitable for endovascular repair, including: 1) adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal proximal aortic neck: a) with a length of at least 7 mm proximal to the aneurysm; b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and c) with an aortic angle of = 10 mm and

DeviceOVATION ABDOMINAL STENT GRAFT SYSTEM
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantTRIVASCULAR INC
Date Received2012-04-11
Decision Date2012-10-05
Notice Date2012-11-08
PMAP120006
SupplementS
Product CodeMIH
Docket Number12M-1110
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address TRIVASCULAR INC 3910 Brickway Blvd santa Rosa, CA 95403
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
P120006Original Filing
S041 2022-12-02 30-day Notice
S040
S039
S038
S037 2020-06-18 Normal 180 Day Track No User Fee
S036 2020-06-09 Special (immediate Track)
S035 2020-03-31 Normal 180 Day Track No User Fee
S034 2020-03-25 30-day Notice
S033
S032 2019-03-25 30-day Notice
S031
S030 2018-02-09 Real-time Process
S029 2017-08-07 30-day Notice
S028 2017-07-19 Real-time Process
S027
S026 2016-07-28 30-day Notice
S025 2016-07-20 30-day Notice
S024 2016-03-18 Normal 180 Day Track No User Fee
S023 2016-02-22 Real-time Process
S022
S021 2015-07-10 30-day Notice
S020 2015-05-04 Real-time Process
S019 2015-04-01 Real-time Process
S018 2014-11-26 30-day Notice
S017 2014-10-21 Real-time Process
S016 2014-10-29 30-day Notice
S015 2014-08-07 Normal 180 Day Track
S014 2014-07-22 Real-time Process
S013 2014-04-17 135 Review Track For 30-day Notice
S012
S011 2014-02-24 30-day Notice
S010 2014-01-31 Normal 180 Day Track
S009 2013-11-12 Normal 180 Day Track
S008 2013-11-04 Special (immediate Track)
S007 2013-10-23 Real-time Process
S006 2013-08-26 30-day Notice
S005 2013-08-12 135 Review Track For 30-day Notice
S004 2013-06-27 Normal 180 Day Track No User Fee
S003 2013-01-31 Normal 180 Day Track No User Fee
S002
S001 2012-10-24 Real-time Process

NIH GUDID Devices

Device IDPMASupp
M701TVAB2680N1 P120006 000
M701TVAB2380N1 P120006 000
M701TVAB2980N1 P120006 000
M701TVAB3480N1 P120006 000
M701TVAI01N1 P120006 000
M701TVAB2080N1 P120006 000
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00850007370046 P120006 001
00850007370053 P120006 001
00850007370411 P120006 001
00850007370060 P120006 001
M701TVEX141445J1 P120006 001
00850007370305 P120006 001
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00850007370251 P120006 001
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00850007370190 P120006 001
00850007370145 P120006 001
00850007370138 P120006 001
00850007370022 P120006 001
M701TVIL142880J1 P120006 001
M701TVIL141680J1 P120006 001
M701TVIL1416160J1 P120006 001
M701TVIL1416140J1 P120006 001
M701TVIL1416120J1 P120006 001
M701TVIL1416100J1 P120006 001
M701TVIL141480J1 P120006 001
M701TVIL1414160J1 P120006 001
M701TVIL1414140J1 P120006 001
M701TVIL1414120J1 P120006 001
M701TVIL1414100J1 P120006 001
M701TVIL141280J1 P120006 001
M701TVIL1418100J1 P120006 001
M701TVIL1418120J1 P120006 001
M701TVIL1428160J1 P120006 001
M701TVIL1428140J1 P120006 001
M701TVIL1428120J1 P120006 001
M701TVIL1428100J1 P120006 001
M701TVIL142280J1 P120006 001
M701TVIL1422140J1 P120006 001
M701TVIL1422120J1 P120006 001
M701TVIL1422100J1 P120006 001
M701TVIL141880J1 P120006 001
M701TVIL1418160J1 P120006 001
M701TVIL1418140J1 P120006 001
M701TVIL1412160J1 P120006 001
M701TVIL1412140J1 P120006 001
M701TVIL1412120J1 P120006 001
M701TVIL1422160J1 P120006 001
M701TVEX101045J1 P120006 001
M701TVEX121245J1 P120006 001
M701TVEX161645J1 P120006 001
M701TVEX181845J1 P120006 001
M701TVEX222245J1 P120006 001
M701TVEX282845J1 P120006 001
M701TVIL141080J1 P120006 001
M701TVIL1410100J1 P120006 001
M701TVIL1410120J1 P120006 001
M701TVIL1410140J1 P120006 001
M701TVIL1410160J1 P120006 001
M701TVIL1412100J1 P120006 001
M701TVCS14G1 P120006 008
00850007370459 P120006 008
M701TVAB2680J1 P120006 020
M701TVAB2080J1 P120006 020
M701TVAB2980J1 P120006 020
M701TVAB2380J1 P120006 020
M701TVAB3480J1 P120006 020
00850007370916 P120006 031
00850007370909 P120006 031
00850007370886 P120006 031
00850007370398 P120006 031
00850007370381 P120006 031
00850007370893 P120006 031

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