Ovation iX Abdominal Stent Graft System

FDA Premarket Approval P120006 S036

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

Endologix requested approval for updating the ifu with the following language:updating the ifu with the following language:“polymer leaks are a unique potential risk of the ovation device platform that have been reported post-market. The complications of polymer leakage in to the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the ovation ix sealing rings have led to intraoperative type ia endoleaks that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the instructions for use. ” this updated language was agreed upon as part of the mitigation strategy of the class i recall of the ovation ix.

DeviceOvation iX Abdominal Stent Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantEndologix, Inc.
Date Received2020-06-09
Decision Date2020-07-09
PMAP120006
SupplementS036
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Endologix, Inc. 3910 Brickway Blvd santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P120006Original Filing
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

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