VENTANA MMR RxDx Panel
FDA premarket approval P200019/S010 · decided 2024-12-20
Approval details
- PMA number
- P200019
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTANA MMR RxDx Panel
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems
- Date received
- 2023-12-11
- Decision date
- 2024-12-20
- Days to decision
- 375 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for assay migration of VENTANA MMR RxDx Panel from the BenchMark ULTRA platform to BenchMark ULTRA PLUS platform.
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