Vascutek L T D Newmains Avenueinchinnan Pa4 9 Pma Numberp210006 Supplement Numbers002 Date Received05 19 2022 Decision Date06 16 2022 Product Code Qsk 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 Vascutek L T D Newmains Avenueinchinnan Pa4 9 Pma Numberp210006 Supplement Numbers002 Date Received05 19 2022 Decision Date06 16 2022 Product Code Qsk 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 P210006S002 Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS002 Date Received05/19/2022 Decision Date06/16/2022 Product Code QSK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Thoraflex Hybrid	2022-06-16