This page includes the latest FDA filings for Abbott Medical6035 Stoneridge Drivepleasanton Ca 94588 Pma Numberp060040 Supplement Numbers089 Date Received10 31 2022 Decision Date01 10 2023 Product Code Dsq Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
---|---|---|
Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS089 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No | HeartMate II Left Ventricular Assist System (LVAS) | 2023-01-10 |