Abiomed Inc 22 Cherry Hill Dr Danvers Ma 01923 Pma Numberp140003 Supplement Numbers106 Date Received10 14 2022 Decision Date01 06 2023 Product Code Ozd Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Abiomed Inc 22 Cherry Hill Dr Danvers Ma 01923 Pma Numberp140003 Supplement Numbers106 Date Received10 14 2022 Decision Date01 06 2023 Product Code Ozd Advisory Committee Cardiovascular Supplement Typereal Time Process 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 P140003S106 ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Impella2.5, ImpellaCP, Impella CP with SmartAssist	2023-01-06