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Development Plan Milestones

Deliverable Due Status
FAST II 6-month follow-up completion Q3 2021 Anticipated
FreedomFlow® pre-market notification 510(k) submission
Q2 2021 Completed
FAST II 30-day follow-up completion Q1 2021 Completed
FAST II electric system enrollment completion Q1 2021 Completed
Electric system IDE approval Q3 2020 Completed
FAST II IDE approval Q4 2018 Completed
FIH (FAST) 6-month follow-up Q3 2018 Completed
FIH (FAST) 30-day follow-up Q1 2018 Completed
FIH (FAST) clinical trial enrollment  Q1 2018 Completed
FDA IDE approval for FIH (FAST) clinical testing Q4 2017 Completed
FDA FIH IDE submission* Q3 2017 Completed
Design verification pre-clinical testing Q2 2017 Completed
Design freeze / design verification testing Q1 2017 Completed
Feasibility testing Q4 2016 Completed
Updated design for over-wire application Q4 2016 Completed

*First-in-Human (FIH) Investigational Device Exemption (IDE)

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