Medtronic8200 Coral Seast N E Mounds View Mn 55112 Pma Numberp100047 Supplement Numbers195 Date Received02 15 2022 Decision Date03 16 2022 Product Code Dsq Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 Numbers195 Date Received02 15 2022 Decision Date03 16 2022 Product Code Dsq Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P100047S195 Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS195 Date Received02/15/2022 Decision Date03/16/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	HeartWare Ventricular Assist (HVAD) System	2022-03-16