VENTANA MMR RxDx Panel
FDA premarket approval P210001/S012 · decided 2024-12-20
Approval details
- PMA number
- P210001
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2023-12-11
- Decision date
- 2024-12-20
- Days to decision
- 375 days
- Decision code
- APPR
- 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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