TREO Abdominal Stent-Graft System

FDA Premarket Approval P190015 S009

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 an increase in the labeled shelf life for the straight extension stent-grafts in the treo abdominal stent-graft system (treo) product family from 2 years to 3 years

DeviceTREO Abdominal Stent-Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBolton Medical Inc.
Date Received2021-01-25
Decision Date2021-04-19
PMAP190015
SupplementS009
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Bolton Medical Inc. 799 International Pkwy sunrise, FL 33325

Supplemental Filings

Supplement NumberDateSupplement Type
P190015Original Filing
S009 2021-01-25 Real-time Process
S008 2020-11-24 30-day Notice
S007 2020-11-23 Normal 180 Day Track No User Fee
S006 2020-10-29 30-day Notice
S005 2020-09-14 30-day Notice
S004
S003
S002 2020-07-23 Special (immediate Track)
S001 2020-06-03 Normal 180 Day Track No User Fee

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