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)