OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P120006 S003

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

Approval of the post-approval study protocol.

DeviceOVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantTRIVASCULAR INC
Date Received2013-01-31
Decision Date2013-04-21
PMAP120006
SupplementS003
Product CodeMIH
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address TRIVASCULAR INC 3910 Brickway Blvd santa Rosa, CA 95403

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
00085000737002 P120006 001
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00850007370312 P120006 001
00850007370435 P120006 001
00850007370442 P120006 001
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00850007370015 P120006 001
00850007370039 P120006 001
00850007370046 P120006 001
00850007370053 P120006 001
00850007370411 P120006 001
00850007370060 P120006 001
M701TVEX141445J1 P120006 001
00850007370305 P120006 001
00850007370299 P120006 001
00850007370282 P120006 001
00850007370107 P120006 001
00850007370091 P120006 001
00850007370077 P120006 001
00850007370008 P120006 001
00850007370428 P120006 001
00850007370213 P120006 001
00850007370183 P120006 001
00850007370176 P120006 001
00850007370169 P120006 001
00850007370152 P120006 001
00850007370114 P120006 001
00850007370121 P120006 001
00850007370275 P120006 001
00850007370268 P120006 001
00850007370251 P120006 001
00850007370244 P120006 001
00850007370237 P120006 001
00850007370220 P120006 001
00850007370206 P120006 001
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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