Medtronic Cardiac Rhythm Disease Management8200 Coral Sea Street N E Mounds View Mn 55112 Pma Numberp010031 Supplement Numbers801 Date Received09 13 2022 Decision Date09 19 2022 Product Code Nik 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 Mounds View Mn 55112 Pma Numberp010031 Supplement Numbers801 Date Received09 13 2022 Decision Date09 19 2022 Product Code Nik 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 P010031S801 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS801 Date Received09/13/2022 Decision Date09/19/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D	2022-09-19