PMA P030011S032

Device: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S032
Product code: LOZ
Decision date: 2015-11-27
Classification: Artificial Heart
Generic name: Artificial heart
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: MODIFICATION TO THE APPROVED POST APPROVAL STUDY FOR THE COMPANION 2 DRIVER SYSTEM, WHICH USES THE INTERMACS REGISTRY AS THE DATA COLLECTION MECHANISM (INTERMACS COMPANION).

Current openFDA PMA Record#

Device: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
Applicant: Syncardia Systems, LLC
PMA number: P030011
Supplement: S032
Product code: LOZ
Generic name: Artificial heart
Decision date: 2015-11-27
Decision code: APPR
Date received: 2015-07-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol - OSB
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: MODIFICATION TO THE APPROVED POST APPROVAL STUDY FOR THE COMPANION 2 DRIVER SYSTEM, WHICH USES THE INTERMACS REGISTRY AS THE DATA COLLECTION MECHANISM (INTERMACS COMPANION).