SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S073 · decided 2019-08-15
Approval details
- PMA number
- P030011
- Supplement
- S073
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2019-07-16
- Decision date
- 2019-08-15
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the addition of a red key tag with caution statement on the key ring of the Companion 2 Driver key.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.