Xvivo Perfusion System (XPS) with Steen Solution Perfusate
FDA premarket approval P180014/S003 · decided 2020-04-24
Approval details
- PMA number
- P180014
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Xvivo Perfusion System (XPS) with Steen Solution Perfusate
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Applicant
- Xvivo Perfusion, Inc.
- Date received
- 2020-01-27
- Decision date
- 2020-04-24
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval for a software upgrade for the XPS System (software version V.5.2.0).
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