GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)

FDA Premarket Approval P200030 S008

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

DeviceGORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS008 Date Received06/28/2022 Decision Date07/27/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-28
Decision Date2022-07-27
PMAP200030
SupplementS008
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressW. L. Gore And Associates, Inc.
32360 N. North Valley Parkway
phoenix, AZ 85085 PMA NumberP200030 Supplement NumberS008 Date Received06/28/2022 Decision Date07/27/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of An Update To The Burst Strength Destructive Testing Sampling Plan For The GORE EXCLUDER Conformable AAA Endoprosthesis

Supplemental Filings

Supplement NumberDateSupplement Type
P200030Original Filing
S008 2022-06-28 30-day Notice
S007 2022-01-20 30-day Notice
S006 2021-11-17 30-day Notice
S005 2021-10-29 30-day Notice
S004 2021-09-07 30-day Notice
S003 2021-05-10 30-day Notice
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

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