OrganOx metra System
FDA premarket approval P200035/S011 · decided 2024-02-22
Approval details
- PMA number
- P200035
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- OrganOx metra System
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Applicant
- Organox Limited
- Date received
- 2023-08-29
- Decision date
- 2024-02-22
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for labeling modifications including the methdos and results of the OrganOx metra® WP01 Long-Term Follow-up PAS. This change is being made in response to the letter from FDA for P200035/R007 dated August 22, 2023. Based upon the information submitted, the PMA supplement is approved.
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