GORE EXCLUDER Conformable AAA Endoprosthesis

FDA Premarket Approval P200030 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

Upgrades to wire processing equipment

DeviceGORE EXCLUDER Conformable AAA Endoprosthesis
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. Gore And Associates, Inc.
Date Received2021-04-06
Decision Date2021-04-15
PMAP200030
SupplementS002
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
S002 2021-04-06 30-day Notice
S001 2021-01-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00733132651078 P200030 000
00733132650934 P200030 000
00733132650941 P200030 000
00733132650958 P200030 000
00733132650965 P200030 000
00733132650972 P200030 000
00733132650989 P200030 000
00733132650996 P200030 000
00733132651009 P200030 000
00733132651016 P200030 000
00733132651023 P200030 000
00733132651030 P200030 000
00733132651047 P200030 000
00733132651054 P200030 000
00733132651061 P200030 000
00733132650927 P200030 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.