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rtg123

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rtg123

Re: wrinklesobw post# 157064

Tuesday, 02/07/2023 11:30:56 AM

Tuesday, February 07, 2023 11:30:56 AM

Post# of 175211
It looks like they submitted the nearly final IDE to save time. All they have to do after the meeting is to include the reports for the containment study and aseptic filling validation and submit the final IDE for approval. I highly doubt there will be a meeting to discuss the containment study.
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