Syncardia Systems Llc1992 E Silverlake Rd Tucson Az 85713 Pma Numberp030011 Supplement Numbers082 Date Received08 23 2022 Decision Date09 22 2022 Product Code Loz 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 Syncardia Systems Llc1992 E Silverlake Rd Tucson Az 85713 Pma Numberp030011 Supplement Numbers082 Date Received08 23 2022 Decision Date09 22 2022 Product Code Loz 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 P030011S082 SYNCARDIA SYSTEMS, LLC1992 E. Silverlake Rd.tucson, AZ 85713 PMA NumberP030011 Supplement NumberS082 Date Received08/23/2022 Decision Date09/22/2022 Product Code LOZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SynCardia temporary Total Artificial Heart (TAH-t) System	2022-09-22