TREO Abdominal Stent-Graft System

FDA Premarket Approval P190015 S006

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

To use an alternative sterilization load configuration for the treo abdominal stent-graft system

DeviceTREO Abdominal Stent-Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBolton Medical Inc.
Date Received2020-10-29
Decision Date2020-10-30
PMAP190015
SupplementS006
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bolton Medical Inc. 799 International Pkwy sunrise, FL 33325

Supplemental Filings

Supplement NumberDateSupplement Type
P190015Original Filing
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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