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.
Approval for adding a manufacturing site for delivery system tips and process changes for inner catheters
| Device | Zilver Vena Venous Self-Expanding Stent |
| Generic Name | Stent, Iliac Vein |
| Applicant | Cook Ireland Ltd. |
| Date Received | 2021-09-27 |
| Decision Date | 2021-10-26 |
| PMA | P200023 |
| Supplement | S002 |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cook Ireland Ltd. o' Halloran Road, National Technology Park limerick |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200023 | Original Filing | |
| S002 | 2021-09-27 | 30-day Notice |
| S001 | 2021-09-02 | Special (immediate Track) |