Cook Ireland L T D O Halloran Roadnational Technology Parklimerick Pma Numberp050017 Supplement Numbers019 Date Received03 07 2022 Decision Date04 04 2022 Product Code Nio 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 Cook Ireland L T D O Halloran Roadnational Technology Parklimerick Pma Numberp050017 Supplement Numbers019 Date Received03 07 2022 Decision Date04 04 2022 Product Code Nio 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 P050017S019 Cook Ireland, Ltd.o'halloran Roadnational Technology Parklimerick  PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Zilver Vascular Stent	2022-04-04