TREO Abdominal Stent-Graft System

FDA Premarket Approval P190015 S002

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 implementation of an in-process inspection step in the manufacturing of the treo abdominal stent-graft system.

DeviceTREO Abdominal Stent-Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBolton Medical Inc.
Date Received2020-07-23
Decision Date2020-08-20
PMAP190015
SupplementS002
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
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
S002 2020-07-23 Special (immediate Track)
S001 2020-06-03 Normal 180 Day Track No User Fee

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