Titan Medical Inc (TMDIF): IDE submission "An IDE application is...

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elMoose

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Sunday, 09/15/2019 5:50:22 PM

Sunday, September 15, 2019 5:50:22 PM

IDE submission

"An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.
"
https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-approval-process

According to Titan
"
IDE Approval Q4 2019
Submit 510(k) Application H1 2020
Submit Technical File for CE Mark H1 2020
Anticipated Regulatory Clearance H2 2020
Projected Initial Launch H2 2020
"
https://titanmedicalinc.com/wp-content/uploads/2019/09/Titan-Medical-Investor-Presentation-September-4-2019.pdf

Last Day of Q4 is last Day of December

So they can submit the IDE any time between now and the last week of November in Q4 to get ID approval in Q4 so it does not have to be the first days of Q3