Medtronic Inc 3576 Unocal Placebuilding Asanta Rosa Ca 95403 Pma Numberp200046 Supplement Numbers012 Date Received10 31 2022 Decision Date11 01 2022 Product Code Npv 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 Inc 3576 Unocal Placebuilding Asanta Rosa Ca 95403 Pma Numberp200046 Supplement Numbers012 Date Received10 31 2022 Decision Date11 01 2022 Product Code Npv 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 P200046S012 Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Harmony™ Delivery Catheter System	2022-11-01