Medtronic8200 Coral Seast N E Mounds View Mn 55112 Pma Numberp100047 Supplement Numbers197 Date Received04 18 2022 Decision Date05 10 2022 Product Code Dsq 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 Medtronic8200 Coral Seast N E Mounds View Mn 55112 Pma Numberp100047 Supplement Numbers197 Date Received04 18 2022 Decision Date05 10 2022 Product Code Dsq 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 Registration(s)

FDA Filings

Device
Company
DeviceDate
Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS197 Date Received04/18/2022 Decision Date05/10/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
HeartWare® Ventricular Assist System2022-05-10

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