VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
FDA premarket approval P200019/S009 · decided 2024-01-26
Approval details
- PMA number
- P200019
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems
- Date received
- 2023-10-30
- Decision date
- 2024-01-26
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).
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