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FDA Closes Manufacturing Module in Imricor’s PMA Submission

8:21am on Thursday 3rd of September, 2026 AEST Healthcare
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FDA Closes Manufacturing Module in Imricor’s PMA Submission

8:21am on Thursday 3rd of September, 2026 AEST
Key Points
  • FDA accepts and closes manufacturing module
  • Module covers seven devices including Vision-MR and RF-5000
  • Pre-approval inspection of manufacturing sites pending
  • Milestone advances modular PMA review process
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