W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 Pma Numberp020004 Supplement Numbers192 Date Received09 06 2022 Decision Date10 05 2022 Product Code Mih Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 Pma Numberp020004 Supplement Numbers192 Date Received09 06 2022 Decision Date10 05 2022 Product Code Mih Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS192 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
GORE® EXCLUDER® AAA Endoprosthesis (AAA)2022-10-05

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