Organ Care System (OCS) Liver
FDA premarket approval P200031 · decided 2021-09-28
Approval details
- PMA number
- P200031
- 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
- 2020-06-30
- Decision date
- 2021-09-28
- Days to decision
- 455 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for Organ Care System (OCS) Liver for the indication of: The TransMedics® Organ Care System (OCS) Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assessment of liver allografts from donors after brain death (DBD) or liver allografts from donors after circulatory death (DCD) <=55 years old and with <=30 mins of warm ischemic time, macrosteatosis <=15%, in a n
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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 |