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Unknown PCCPs

46 of the 143 FDA-authorized PCCPs are Unknown plans, 4 of them AI/SaMD. Here is the full list, newest first.

Other PCCP types

Retraining PCCPs (41)Compatibility expansion PCCPs (16)I/O expansion PCCPs (14)Other PCCPs (9)Architecture change PCCPs (7)Panel expansion PCCPs (3)Hardware PCCPs (3)Change management PCCPs (2)Model update PCCPs (2)

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We read the Unknown PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.

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Source: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.

This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.