SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
FDA premarket approval P030011/S042 · decided 2016-03-17
Approval details
- PMA number
- P030011
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2016-02-22
- Decision date
- 2016-03-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Change to add three alternate, equivalent subcomponents (one capacitor, two resistors) on the Companion 2 Driver Main Printed Circuit Board Assembly (PCBA).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.