Vascutek L T D Newmains Avenueinchinnan Pa4 9 Pma Numberp210006 Supplement Numbers003 Date Received07 01 2022 Decision Date09 29 2022 Product Code Qsk Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Vascutek L T D Newmains Avenueinchinnan Pa4 9 Pma Numberp210006 Supplement Numbers003 Date Received07 01 2022 Decision Date09 29 2022 Product Code Qsk Advisory Committee Cardiovascular Supplement Typereal Time Process 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 P210006S003 Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS003 Date Received07/01/2022 Decision Date09/29/2022 Product Code QSK  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Thoraflex™ Hybrid	2022-09-29