VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
FDA premarket approval P200019/S004 · decided 2022-07-21
Approval details
- PMA number
- P200019
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- 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
- 2022-02-16
- Decision date
- 2022-07-21
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.
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