VENTANA MMR RxDx Panel
FDA premarket approval P210001/S013 · decided 2024-12-18
Approval details
- PMA number
- P210001
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2024-07-17
- Decision date
- 2024-12-18
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- approval to include a companion diagnostic indication to identify adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, who are eligible for treatment with IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel, followed by IMFINZI® (durvalumab) as a single agent.
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