Abiomed Inc 22 Cherry Hill Dr Danvers Ma 01923 Pma Numberp140003 Supplement Numbers097 Date Received03 24 2022 Decision Date04 12 2022 Product Code Ozd 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 Abiomed Inc 22 Cherry Hill Dr Danvers Ma 01923 Pma Numberp140003 Supplement Numbers097 Date Received03 24 2022 Decision Date04 12 2022 Product Code Ozd 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 P140003S097 ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS097 Date Received03/24/2022 Decision Date04/12/2022 Product Code OZD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist	2022-04-12