This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Updates to the labeling with final clinical data from the mimics-2 study
| Device | BioMimics 3D Vascular Stent System |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Veryan Medical Ltd. |
| Date Received | 2020-06-25 |
| Decision Date | 2020-08-13 |
| PMA | P180003 |
| Supplement | S003 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Veryan Medical Ltd. unit 15, City Business Centre, Brighton Rd horsham RH13 |
| 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 |
| 05391526850381 | P180003 | 000 |
| 05391526850398 | P180003 | 000 |
| 05391526850404 | P180003 | 000 |
| 05391526850411 | P180003 | 000 |
| 05391526850428 | P180003 | 000 |
| 05391526850435 | P180003 | 000 |
| 05391526850442 | P180003 | 000 |
| 05391526850459 | P180003 | 000 |
| 05391526850510 | P180003 | 000 |
| 05391526850503 | P180003 | 000 |
| 05391526850497 | P180003 | 000 |
| 05391526850480 | P180003 | 000 |
| 05391526850473 | P180003 | 000 |
| 05391526850466 | P180003 | 000 |
| 05391526850749 | P180003 | 012 |
| 05391526850732 | P180003 | 012 |
| 05391526850725 | P180003 | 012 |
| 05391526850718 | P180003 | 012 |
| 05391526850701 | P180003 | 012 |
| 05391526850695 | P180003 | 012 |
| 05391526850756 | P180003 | 012 |
| 05391526850763 | P180003 | 012 |
| 05391526850770 | P180003 | 012 |
| 05391526850787 | P180003 | 012 |
| 05391526850794 | P180003 | 012 |
| 05391526850800 | P180003 | 012 |
| 05391526850817 | P180003 | 012 |
| 05391526850824 | P180003 | 012 |
| 05391526850688 | P180003 | 012 |