VENTANA MMR RxDx Panel
FDA premarket approval P200019 · decided 2021-04-22
Approval details
- PMA number
- P200019
- Trade name
- VENTANA MMR RxDx Panel
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems
- Date received
- 2020-03-16
- Decision date
- 2021-04-22
- Days to decision
- 402 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the Ventana MMR RxDx Pavel as a CDx for identifying patients with endometrial cancer with dMMR status who may benefit from treatment with Jemperli.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.