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Friday, April 05, 2024 9:03:05 AM
Their recent PR trumps the 2021 PR.
This is a brand new application. Estar or not, they are at step 1 in the process.
PMA has been submitted, they will now wait to see if the application is filed for further review.
They even included the FDA link in the PR this time so you can follow along with the steps.
If it accepted for review the wait will be up to 6 months.
No debate, FACT. As always.
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