Gore Excluder Conformable AAA Endoprosthesis

FDA Premarket Approval P200030 S001

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

Implementation of the use of an alternate polytetrafluoroethylene (ptfe) aqueous-based formulation for coating the processing mandrels used as manufacturing aids during the manufacturing of gore cexc components

DeviceGore Excluder Conformable AAA Endoprosthesis
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. Gore And Associates, Inc.
Date Received2021-01-22
Decision Date2021-02-01
PMAP200030
SupplementS001
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address W. L. Gore And Associates, Inc. 32360 N. North Valley Parkway phoenix, AZ 85085

Supplemental Filings

Supplement NumberDateSupplement Type
P200030Original Filing
S001 2021-01-22 30-day Notice

NIH GUDID Devices

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