Medtronic Inc 7000 Central Avenue Neminneapolis Mn 55432 3576 Pma Numberp860004 Supplement Numbers397 Date Received08 19 2022 Decision Date09 16 2022 Product Code Lkk Advisory Committee General Hospital 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 Medtronic Inc 7000 Central Avenue Neminneapolis Mn 55432 3576 Pma Numberp860004 Supplement Numbers397 Date Received08 19 2022 Decision Date09 16 2022 Product Code Lkk Advisory Committee General Hospital 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 P860004S397 MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS397 Date Received08/19/2022 Decision Date09/16/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Master SynchroMed™ II Infusion System	2022-09-16