PMA P030011S073
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S073
- Product code
- LOZ
- Decision date
- 2019-08-15
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for the addition of a red key tag with caution statement on the key ring of the Companion 2 Driver key.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S073
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2019-08-15
- Decision code
- APPR
- Date received
- 2019-07-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a red key tag with caution statement on the key ring of the Companion 2 Driver key.