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 NumberS005 Date Received10/14/2021 Decision Date03/01/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2021-10-14 |
| Decision Date | 2022-03-01 |
| PMA | P180003 |
| Supplement | S005 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 NumberS005 Date Received10/14/2021 Decision Date03/01/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of An Alternative Sterilization Site Located At Synergy Health Sterilization UK Ltd, STERIS AST Unit 1, Alpha Court, Capitol Park, Thorne, DN8 5TZ, United Kingdom, Addition Of A New Sterilization Cycle, An Alternative Load Configuration And Ability To Perform Endotoxin Testing On Non-sterile Samples In Your Current Laboratory. |
| 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 |