SynCardia temporary Total Artificial Heart (TAH-t) System
FDA premarket approval P030011/S087 · decided 2023-10-18
Approval details
- PMA number
- P030011
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2023-09-21
- Decision date
- 2023-10-18
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- change in the roller mixer used to produce components for the Syncardia TAH-t
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.