Medtronic Inc 710 Medtronic Parkwayminneapolis Mn 55432 Pma Numberp130021 Supplement Numbers128 Date Received11 29 2022 Decision Date12 01 2022 Product Code Npt 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 710 Medtronic Parkwayminneapolis Mn 55432 Pma Numberp130021 Supplement Numbers128 Date Received11 29 2022 Decision Date12 01 2022 Product Code Npt 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 P130021S128 Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS128 Date Received11/29/2022 Decision Date12/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst	2022-12-01