William Cook Europe Apssandet 6 Dk 4632bjaeverskov Pma Numberp180001 Supplement Numbers005 Date Received05 05 2022 Decision Date06 02 2022 Product Code Mih 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 William Cook Europe Apssandet 6 Dk 4632bjaeverskov Pma Numberp180001 Supplement Numbers005 Date Received05 05 2022 Decision Date06 02 2022 Product Code Mih 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 P180001S005 WILLIAM COOK EUROPE APSsandet 6, Dk-4632bjaeverskov  PMA NumberP180001 Supplement NumberS005 Date Received05/05/2022 Decision Date06/02/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Zenith Dissection Endovascular System	2022-06-02