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Yes if the FDA grants marketing authorization (e.g., premarket approval, De Novo clearance) for the device on or before July 24, 2026. No if the FDA rejects the application, issues a complete response letter, or fails to render a decision by that date.
Resolves Yes if Yes if the FDA grants marketing authorization (e.g., premarket approval, De Novo clearance) for the device on or before July 24, 2026. No if the FDA rejects the application, issues a complete response letter, or fails to render a decision by that date.
Outcome verified from fda.gov.
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