FDA.reportPublic FDA data

SYNCARDIA SYSTEMS, LLC

Matched from indexed company URL: Syncardia Systems, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037610173003761017SYNCARDIA SYSTEMS, LLC1N2026-01-011992 E Silverlake Rd TUCSON AZ US 85713

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
642801187039076P030011SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)LOZ2004-10-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOZ22004-10-15

PMA#

SynCardia temporary Total Artificial Heart (TAH-t) System

2022-09-22

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 C...

68 records. Showing 1-40. Next

GUDID#