Alto Abdominal Stent Graft System

FDA Premarket Approval P120006 S035

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 for the alto™ case selection and sizing study post-approval study protocol.

DeviceAlto Abdominal Stent Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantEndologix, Inc.
Date Received2020-03-31
Decision Date2020-06-16
PMAP120006
SupplementS035
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Endologix, Inc. 3910 Brickway Blvd santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P120006Original Filing
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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