post market pma supplement

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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012

The manufacturer is expected to apply post-market phase changes to the product. Assess the following and prepare an appropriate post-market supplement rationale inclusive of PMA type category and high-level overview of rationale to be included in submission. 1) Modified design/components including material change. 2) Change in the controls of the manufacturing environment.

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