Organ Care System (OCS) Liver
FDA premarket approval P200031/S009 · decided 2024-10-11
Approval details
- PMA number
- P200031
- Supplement
- S009
- Supplement type
- 30-Day Notice
- 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
- 2024-09-20
- Decision date
- 2024-10-11
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- change in manufacturing process
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 |