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 instructions for use (ifu) to provide clarifications and new information regarding vessel measurement and stent selection
| Device | Abre Venous self-expanding stent system |
| Generic Name | Stent, Iliac Vein |
| Applicant | Medtronic Vascular, Inc. |
| Date Received | 2021-10-13 |
| Decision Date | 2021-11-05 |
| PMA | P200026 |
| Supplement | S003 |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular, Inc. 3033 Campus Drive plymouth, MN 55441 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200026 | Original Filing | |
| S005 | 2022-06-17 | Normal 180 Day Track No User Fee |
| S004 | 2022-01-28 | 30-day Notice |
| S003 | 2021-10-13 | Special (immediate Track) |
| S002 | 2021-06-11 | 30-day Notice |
| S001 | 2021-04-08 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00643169796478 | P200026 | 000 |
| 00643169796300 | P200026 | 000 |
| 00643169796294 | P200026 | 000 |
| 00643169796287 | P200026 | 000 |
| 00643169796263 | P200026 | 000 |
| 00643169796256 | P200026 | 000 |
| 00643169796249 | P200026 | 000 |
| 00643169796232 | P200026 | 000 |
| 00643169796225 | P200026 | 000 |
| 00643169796201 | P200026 | 000 |
| 00643169796195 | P200026 | 000 |
| 00643169796188 | P200026 | 000 |
| 00643169796171 | P200026 | 000 |
| 00643169796164 | P200026 | 000 |
| 00643169796317 | P200026 | 000 |
| 00643169796324 | P200026 | 000 |
| 00643169796331 | P200026 | 000 |
| 00643169796461 | P200026 | 000 |
| 00643169796454 | P200026 | 000 |
| 00643169796447 | P200026 | 000 |
| 00643169796430 | P200026 | 000 |
| 00643169796423 | P200026 | 000 |
| 00643169796416 | P200026 | 000 |
| 00643169796409 | P200026 | 000 |
| 00643169796393 | P200026 | 000 |
| 00643169796386 | P200026 | 000 |
| 00643169796379 | P200026 | 000 |
| 00643169796362 | P200026 | 000 |
| 00643169796355 | P200026 | 000 |
| 00643169796348 | P200026 | 000 |
| 00643169796157 | P200026 | 000 |