Abiomed Inc 22 Cherry Hill Drivedanvers Ma 01923 Pma Numberp170011 Supplement Numbers036 Date Received12 17 2021 Decision Date03 16 2022 Product Code Pyx Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 Numbers036 Date Received12 17 2021 Decision Date03 16 2022 Product Code Pyx 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.

FDA Filings

Device Company	Device	Date
PMA P170011S036 Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS036 Date Received12/17/2021 Decision Date03/16/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Impella RP and Impella RP with SmartAssist	2022-03-16