VENTANA MMR RxDx Panel
FDA premarket approval P210001/S008 · decided 2023-05-26
Approval details
- PMA number
- P210001
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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
- 2022-11-29
- Decision date
- 2023-05-26
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval of PAS that was submitted to comply with the condition of approval #1 which required providing data to support the analytical sensitivity of the VENTANA MMR RxDx Panel for the solid tumor indication.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.