Medtronic Inc 8200 Coral Sea Streetmounds View Mn 55112 Pma Numberp200028 Supplement Numbers012 Date Received07 15 2022 Decision Date10 12 2022 Product Code Oae Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Medtronic Inc 8200 Coral Sea Streetmounds View Mn 55112 Pma Numberp200028 Supplement Numbers012 Date Received07 15 2022 Decision Date10 12 2022 Product Code Oae Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 P200028S012 Medtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS012 Date Received07/15/2022 Decision Date10/12/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	DiamondTemp Ablation System™ with the EnSite™ X Mapping System	2022-10-12