Medtronic Cardiac Rhythm Disease Management8200 Coral Sea Street N E Mounds View Mn 55112 Pma Numberp010031 Supplement Numbers811 Date Received01 06 2023 Decision Date01 13 2023 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 Numbers811 Date Received01 06 2023 Decision Date01 13 2023 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 P010031S811 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS811 Date Received01/06/2023 Decision Date01/13/2023 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt	2023-01-13