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.
| Device | BioMimics 3D Vascular Stent System |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Veryan Medical Ltd.unit 15, City Business Centre, Brighton Rdhorsham RH13 PMA NumberP180003 Supplement NumberS006 Date Received03/09/2022 Decision Date04/05/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-09 |
| Decision Date | 2022-04-05 |
| PMA | P180003 |
| Supplement | S006 |
| 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 PMA NumberP180003 Supplement NumberS006 Date Received03/09/2022 Decision Date04/05/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval To Retain Stents In Production Following An In-process Quality Control Test |
| 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 |