Siemens Healthcare Diagnostics333 Coney Streetwalpole Ma 02032 1516 Pma Numberp950021 Supplement Numbers025 Date Received03 22 2022 Decision Date03 29 2022 Product Code Mtg Advisory Committee Immunology 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 Siemens Healthcare Diagnostics333 Coney Streetwalpole Ma 02032 1516 Pma Numberp950021 Supplement Numbers025 Date Received03 22 2022 Decision Date03 29 2022 Product Code Mtg Advisory Committee Immunology 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 P950021S025 SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP950021 Supplement NumberS025 Date Received03/22/2022 Decision Date03/29/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Atellica® IM Prostate-Specific Antigen (PSA) Assay	2022-03-29