Organ Care System (OCS) Liver
FDA premarket approval P200031/S003 · decided 2023-05-09
Approval details
- PMA number
- P200031
- Supplement
- S003
- 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
- 2023-03-06
- Decision date
- 2023-05-09
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.
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 |