OCS Heart System
FDA premarket approval P180051/S001 · decided 2022-04-27
Approval details
- PMA number
- P180051
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OCS Heart System
- Generic name
- Organ care system (OCS) heart system
- Applicant
- TransMedics, Inc.
- Date received
- 2021-11-08
- Decision date
- 2022-04-27
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- QIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for the Organ Care System (OCS) Heart System for expanding the indication to include donation-after-circulatory-death (DCD) donor hearts. The device is indicated for the preservation of donation-after-brain-death (DBD) hearts initially deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time). The OCS Heart System is also indicated for the ex vivo reanimation, fu
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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 |