XPS with Steen Solution Perfusate
FDA premarket approval P180014/S011 · decided 2024-09-20
Approval details
- PMA number
- P180014
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2024-06-20
- Decision date
- 2024-09-20
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval for change from a leucocyte filter to an arterial filter, Medtronic Affinity AF100 Arterial Filter (K122760).
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