Abbott Medical6035 Stoneridge Drivepleasanton Ca 94588 Pma Numberp160054 Supplement Numbers049 Date Received09 15 2022 Decision Date10 14 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 Abbott Medical6035 Stoneridge Drivepleasanton Ca 94588 Pma Numberp160054 Supplement Numbers049 Date Received09 15 2022 Decision Date10 14 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 Filings

Device Company	Device	Date
PMA P160054S049 Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS049 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	HeartMate 3™ Left Ventricular Assist System (LVAS)	2022-10-14