Medtronic Cardiac Rhythm Disease Management8200 Coral Sea Street N E Ms Mvs11mounds View Mn 55112 Pma Numberp980016 Supplement Numbers811 Date Received03 30 2022 Decision Date04 15 2022 Product Code Lws 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 Cardiac Rhythm Disease Management8200 Coral Sea Street N E Ms Mvs11mounds View Mn 55112 Pma Numberp980016 Supplement Numbers811 Date Received03 30 2022 Decision Date04 15 2022 Product Code Lws 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 P980016S811 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS811 Date Received03/30/2022 Decision Date04/15/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD	2022-04-15