Organ Care System (OCS) Liver
FDA premarket approval P200031/S010 · decided 2025-07-01
Approval details
- PMA number
- P200031
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Organ Care System (OCS) Liver
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Applicant
- TransMedics, Inc.
- Date received
- 2024-09-26
- Decision date
- 2025-07-01
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- approval for modifications to the organ chamber hepatic artery (HA) and portal vein (PV) connectors of the OCS Liver System to support improved manufacturability of the organ chamber
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OCS Heart Leukocyte Depleting Filter (K231362) | TransMedics, Inc. | 2023-10-31 |
| OCS Lung Donor Flush Set (K222535) | TransMedics, Inc. | 2022-11-18 |
| OCS Lung Solution (K211314) | TransMedics, Inc. | 2021-07-29 |