Medtronic Inc 8200 Coral Sea Street Nems Mv S11mounds View Mn 55112 Pma Numberp010015 Supplement Numbers497 Date Received04 27 2022 Decision Date05 03 2022 Product Code Lwp 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 8200 Coral Sea Street Nems Mv S11mounds View Mn 55112 Pma Numberp010015 Supplement Numbers497 Date Received04 27 2022 Decision Date05 03 2022 Product Code Lwp 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 P010015S497 MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS497 Date Received04/27/2022 Decision Date05/03/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P	2022-05-03