W L Gore 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

FDA Filings

This page includes the latest FDA filings for W L Gore 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. 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 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
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)2022-07-27

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