XPS with Steen Solution Perfusate
FDA premarket approval P180014 · decided 2019-04-26
Approval details
- PMA number
- P180014
- Trade name
- XPS with Steen Solution Perfusate
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Applicant
- Xvivo Perfusion, Inc.
- Date received
- 2018-05-10
- Decision date
- 2019-04-26
- Days to decision
- 351 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval for the XPS with Steen Solution Perfusate. This device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation.
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