Angel Medical Systems Inc 788 Shrewsbury Ave Suite 2200tinton Falls Nj 07724 Pma Numberp150009 Supplement Numbers008 Date Received08 19 2022 Decision Date09 21 2022 Product Code Qbi 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 Angel Medical Systems Inc 788 Shrewsbury Ave Suite 2200tinton Falls Nj 07724 Pma Numberp150009 Supplement Numbers008 Date Received08 19 2022 Decision Date09 21 2022 Product Code Qbi 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 P150009S008 ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS008 Date Received08/19/2022 Decision Date09/21/2022 Product Code QBI  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	AngelMed Guardian System	2022-09-21