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 | Abre Venous Self-expanding Stent System |
| Generic Name | Stent, Iliac Vein |
| Applicant | Medtronic Vascular, Inc.3033 Campus Driveplymouth, MN 55441 PMA NumberP200026 Supplement NumberS005 Date Received06/17/2022 Decision Date07/22/2022 Product Code QAN Advisory Committee Cardiovascular Clinical TrialsNCT03038438 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2022-06-17 |
| Decision Date | 2022-07-22 |
| PMA | P200026 |
| Supplement | S005 |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular, Inc. 3033 Campus Drive plymouth, MN 55441 PMA NumberP200026 Supplement NumberS005 Date Received06/17/2022 Decision Date07/22/2022 Product Code QAN Advisory Committee Cardiovascular Clinical TrialsNCT03038438 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Updates To The Labeling To Include Long-term Results From The ABRE Continued Follow-Up Study |
| 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 |