Organ Care System (OCS) Lung System
FDA premarket approval P160013/S001 · decided 2018-06-14
Approval details
- PMA number
- P160013
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Organ Care System (OCS) Lung System
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Applicant
- TransMedics, Inc.
- Date received
- 2018-04-06
- Decision date
- 2018-06-14
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- QBA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for protocol for post-approval study (PAS) protocol.
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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 |