Berlin Heart Inc 9391 Grogan S Mill Road Suite A 6the Woodlands Tx 77380 Pma Numberp160035 Supplement Numbers024 Date Received11 08 2021 Decision Date03 04 2022 Product Code Dsq Advisory Committee Cardiovascular Supplement Type135 Review Track For 30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Berlin Heart Inc 9391 Grogan S Mill Road Suite A 6the Woodlands Tx 77380 Pma Numberp160035 Supplement Numbers024 Date Received11 08 2021 Decision Date03 04 2022 Product Code Dsq Advisory Committee Cardiovascular Supplement Type135 Review Track For 30 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 P160035S024 Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS024 Date Received11/08/2021 Decision Date03/04/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	EXCOR® Pediatric Ventricular Assist	2022-03-04