Organ Care System (OCS) Lung System
FDA premarket approval P160013/S002 · decided 2019-05-31
Approval details
- PMA number
- P160013
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2018-08-14
- Decision date
- 2019-05-31
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- QBA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for the Organ Care System (OCS) Lung System. The TransMedics Organ Care System (OCS) Lung is a portable, normothermic organ perfusion, ventilation and monitoring medical device indicated for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. The device allows for ex vivo assessment of donor lungs prior to transplantation.
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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 |