Medtronic8200 Coral Seast N E Mounds View Mn 55112 Pma Numberp100047 Supplement Numbers205 Date Received01 19 2023 Decision Date02 02 2023 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 Numbers205 Date Received01 19 2023 Decision Date02 02 2023 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 Filings

Device Company	Device	Date
PMA P100047S205 Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS205 Date Received01/19/2023 Decision Date02/02/2023 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 System, HeartWare® System	2023-02-02