Organ Care System (OCS) Liver
FDA premarket approval P200031/S012 · decided 2025-12-16
Approval details
- PMA number
- P200031
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2025-11-25
- Decision date
- 2025-12-16
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- approval for a change in the pressure test condition in the inline leak test performed during assembly.
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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 |