XVIVO Perfusion System (XPS) with STEEN Solution
FDA premarket approval P180014/S010 · decided 2023-08-09
Approval details
- PMA number
- P180014
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- XVIVO Perfusion System (XPS) with STEEN Solution
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Applicant
- Xvivo Perfusion, Inc.
- Date received
- 2023-07-10
- Decision date
- 2023-08-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval of the revised protocol (version 4.0) for the post-approval study (PAS) protocol.
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