VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
FDA premarket approval P200019/S006 · decided 2022-11-10
Approval details
- PMA number
- P200019
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2022-10-14
- Decision date
- 2022-11-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Changes to a manufacturing process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.