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.
In-process stent quality control changes, a component supplier manufacturing location change and part number changes
| Device | BioMimics 3D Vascular Stent System |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Veryan Medical Ltd. |
| Date Received | 2020-03-16 |
| Decision Date | 2020-04-10 |
| PMA | P180003 |
| Supplement | S002 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |