Berlin Heart Inc 9391 Grogan S Mill Road Suite A 6the Woodlands Tx 77380 Pma Numberp160035 Supplement Numbers028 Date Received07 15 2022 Decision Date08 12 2022 Product Code Dsq Advisory Committee Cardiovascular 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 Berlin Heart Inc 9391 Grogan S Mill Road Suite A 6the Woodlands Tx 77380 Pma Numberp160035 Supplement Numbers028 Date Received07 15 2022 Decision Date08 12 2022 Product Code Dsq Advisory Committee Cardiovascular 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 P160035S028 Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS028 Date Received07/15/2022 Decision Date08/12/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	EXCOR Pediatric Ventricular Assist	2022-08-12