W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 1505 Pma Numberp050006 Supplement Numbers104 Date Received11 18 2022 Decision Date12 15 2022 Product Code Mlv Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 Numbers104 Date Received11 18 2022 Decision Date12 15 2022 Product Code Mlv Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P050006S104 W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS104 Date Received11/18/2022 Decision Date12/15/2022 Product Code MLV  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	GORE® CARDIOFORM ASD Occluder	2022-12-15