XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
FDA premarket approval P180014/S007 · decided 2022-07-14
Approval details
- PMA number
- P180014
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2021-12-08
- Decision date
- 2022-07-14
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval for a manufacturing site located at IPAX Inc. as the new contract manufacturer for manufacturing the XVIVO Perfusion System.
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