Abiomed Inc 22 Cherry Hill Drivedanvers Ma 01923 Pma Numberp170011 Supplement Numbers042 Date Received06 03 2022 Decision Date07 01 2022 Product Code Pyx 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 Drivedanvers Ma 01923 Pma Numberp170011 Supplement Numbers042 Date Received06 03 2022 Decision Date07 01 2022 Product Code Pyx 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 P170011S042 Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS042 Date Received06/03/2022 Decision Date07/01/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist	2022-07-01