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    FDA Submission Materials for Filshie Clip (Mark VI) System – P920046/S012 (Femcare Ltd. & FDA Decision)

    FDA Submission Materials for Filshie Clip (Mark VI) System – P920046/S012 (Femcare Ltd. & FDA Decision)

    $69.00 USD
    $69.00 USD
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    Original Request Contents: All materials related to submission and approval of submission no. P920046/S012 ("Approval for revisions to the Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI) System"), including materials from Femcare Ltd. and the FDA decision
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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