W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 1505 Pma Numberp050006 Supplement Numbers100 Date Received06 06 2022 Decision Date07 06 2022 Product Code Mlv Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 1505 Pma Numberp050006 Supplement Numbers100 Date Received06 06 2022 Decision Date07 06 2022 Product Code Mlv Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 85085-1505 PMA NumberP050006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code MLV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
GORE CARDIOFORM Septal Occluder2022-07-06

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