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Guidance for Industry and FDA Staff Premarket Approval Application Filing Review Document issued on: May 1, 2003, This document supersedes PMA Filing Decisions (P90-2), dated May 18, 1990, and PMA
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PMA filing decisions p90 refers to the 90th decision made regarding a Pre-Market Approval submission.
Medical device manufacturers or sponsors who have submitted a Pre-Market Approval application are required to file pma filing decisions p90.
To fill out pma filing decisions p90, the specific details and information requested in the decision must be provided accurately.
The purpose of pma filing decisions p90 is to assess and provide a decision on the submitted Pre-Market Approval application.
The specific information requested may vary but typically includes details about the medical device, its safety and effectiveness data, manufacturing processes, labeling, and other relevant information.
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