Organ Care System (OCS) Heart System
FDA premarket approval P180051/S003 · decided 2023-05-09
Approval details
- PMA number
- P180051
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Organ Care System (OCS) Heart System
- Generic name
- Organ care system (OCS) heart system
- Applicant
- TransMedics, Inc.
- Date received
- 2023-03-06
- Decision date
- 2023-05-09
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- QIK
- Advisory committee
- Cardiovascular
- 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.
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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 |