VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM
FDA premarket approval P200019/S008 · decided 2023-11-08
Approval details
- PMA number
- P200019
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems
- Date received
- 2023-10-26
- Decision date
- 2023-11-08
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- addition of an alternative supplier for dispenser component parts
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