Abiomed Inc 22 Cherry Hill Drivedanvers Ma 01923 Pma Numberp170011 Supplement Numbers047 Date Received11 03 2022 Decision Date12 05 2022 Product Code Pyx Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee 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 Drivedanvers Ma 01923 Pma Numberp170011 Supplement Numbers047 Date Received11 03 2022 Decision Date12 05 2022 Product Code Pyx Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee 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 P170011S047 Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Impella RP, Impella RP with SmartAssist	2022-12-05