VENTANA MMR RxDx Panel
FDA premarket approval P210001/S005 · decided 2022-05-20
Approval details
- PMA number
- P210001
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- VENTANA MMR RxDx Panel
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2022-04-28
- Decision date
- 2022-05-20
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval of the clinical protocol entitled Statistical Analysis Plan for MK-3475 dMMR VENTANA MMR RxDx Panel Post Approval Analysis.
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