W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 1505 Pma Numberp050006 Supplement Numbers105 Date Received12 15 2022 Decision Date12 21 2022 Product Code Mlv 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 1505 Pma Numberp050006 Supplement Numbers105 Date Received12 15 2022 Decision Date12 21 2022 Product Code Mlv 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 Filings

Device Company	Device	Date
PMA P050006S105 W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS105 Date Received12/15/2022 Decision Date12/21/2022 Product Code MLV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder	2022-12-21