XPS with Steen Solution Perfusate
FDA premarket approval P180014/S012 · decided 2025-05-08
Approval details
- PMA number
- P180014
- Supplement
- S012
- 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
- 2024-08-07
- Decision date
- 2025-05-08
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval for changes to the sterilization procedure for the perfusate gas monitor (PGM) sensors of the XPS System.
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