SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
FDA premarket approval P030011 · decided 2004-10-15
Approval details
- PMA number
- P030011
- Trade name
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2003-04-11
- Decision date
- 2004-10-15
- Days to decision
- 553 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T). THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANT IN CARDIAC TRANSPLANT-ELIGIBLE CANDIDATES AT RISK OF IMMINENT DEATH FROM BIVENTRICULAR FAILURE. ALSO, THE TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) IS INTENDED FOR USE INSIDE THE HOSPITAL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.