Medtronic Vascular3576 Unocal Placesanta Rosa Ca 95403 Pma Numberp110013 Supplement Numbers116 Date Received03 23 2022 Decision Date04 19 2022 Product Code Niq 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 Medtronic Vascular3576 Unocal Placesanta Rosa Ca 95403 Pma Numberp110013 Supplement Numbers116 Date Received03 23 2022 Decision Date04 19 2022 Product Code Niq 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 P110013S116 Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP110013 Supplement NumberS116 Date Received03/23/2022 Decision Date04/19/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Resolute Integrity Zotarolimus-Eluting Coronary Stent System – RX and OTW	2022-04-19