XVIVO Perfusion System with STEEN Solution Perfusate
FDA premarket approval P180014/S005 · decided 2020-10-23
Approval details
- PMA number
- P180014
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- XVIVO Perfusion System with STEEN Solution Perfusate
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Applicant
- Xvivo Perfusion, Inc.
- Date received
- 2020-09-23
- Decision date
- 2020-10-23
- 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 for the post-approval study (PAS) protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.