PMA P030011S036
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S036
- Product code
- LOZ
- Decision date
- 2015-12-09
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- APPROVAL FOR THE ADDITION OF TWO WARNINGS TO THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S036
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2015-12-09
- Decision code
- APPR
- Date received
- 2015-10-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF TWO WARNINGS TO THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL.