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EDAP TMS SA Message Board

  • chestor_investor chestor_investor Mar 21, 2013 8:55 AM Flag

    Acceptance and Filing Review for PMA Applications - Guidance Part 2

    Filing Decision 1: Were the clinical study data collected and analyzed per the protocol?
    Filing Decision 2: Were the nonclinical and clinical data collected on the final design of the device (i.e., the device design intended to be marketed)?
    Filing Decision 3: Were the patient/study10 population and endpoints consistent with the proposed indications?

    Appendix A. Checklists for Acceptance and Filing of PMAs
    Checklist for Acceptance Review for PMAs

 
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