Medtronic Ats Medical Inc 3800 Annapolis Lane Suite 175plymouth Mn 55447 Pma Numberp990046 Supplement Numbers065 Date Received09 26 2022 Decision Date10 21 2022 Product Code Lwq 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 Ats Medical Inc 3800 Annapolis Lane Suite 175plymouth Mn 55447 Pma Numberp990046 Supplement Numbers065 Date Received09 26 2022 Decision Date10 21 2022 Product Code Lwq 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 P990046S065 MEDTRONIC ATS MEDICAL, INC.3800 Annapolis Lane, Suite 175plymouth, MN 55447 PMA NumberP990046 Supplement NumberS065 Date Received09/26/2022 Decision Date10/21/2022 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve – AP360	2022-10-21