Approval for the biomimics 3d vascular stent system. The device is indicated to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal arteries, with reference vessel diameters ranging from 4. 0 - 6. 0 mm and lesion lengths up to 140 mm.
| Device | BioMimics 3D Vascular Stent System |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Veryan Medical Ltd. |
| Date Received | 2018-01-09 |
| Decision Date | 2018-10-04 |
| Notice Date | 2018-10-19 |
| PMA | P180003 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 18M-3841 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Veryan Medical Ltd. unit 15, City Business Centre, Brighton Rd horsham RH13 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180003 | Original Filing | |
| S006 | 2022-03-09 | 30-day Notice |
| S005 | 2021-10-14 | Normal 180 Day Track |
| S004 | 2021-03-17 | 30-day Notice |
| S003 | 2020-06-25 | Normal 180 Day Track No User Fee |
| S002 | 2020-03-16 | 30-day Notice |
| S001 | 2020-03-02 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 05391526850527 | P180003 | 000 |
| 05391526850398 | P180003 | 000 |
| 05391526850404 | P180003 | 000 |
| 05391526850411 | P180003 | 000 |
| 05391526850428 | P180003 | 000 |
| 05391526850435 | P180003 | 000 |
| 05391526850442 | P180003 | 000 |
| 05391526850459 | P180003 | 000 |
| 05391526850466 | P180003 | 000 |
| 05391526850473 | P180003 | 000 |
| 05391526850480 | P180003 | 000 |
| 05391526850497 | P180003 | 000 |
| 05391526850503 | P180003 | 000 |
| 05391526850510 | P180003 | 000 |
| 05391526850381 | P180003 | 000 |