Medtronic Vascular3576 Unocal Placesanta Rosa Ca 95403 Pma Numberp160043 Supplement Numbers064 Date Received11 29 2022 Decision Date12 01 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 Numberp160043 Supplement Numbers064 Date Received11 29 2022 Decision Date12 01 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 P160043S064 MEDTRONIC VASCULAR3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP160043 Supplement NumberS064 Date Received11/29/2022 Decision Date12/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin	2022-12-01