Product code PRL
- Device name
- Iliac Covered Stent, Arterial
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For the treatment of de novo or restenotic lesions found in iliac arteries
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P120003S007 | iCast Covered Stent System | Atrium Medical Corp. | 2026-05-13 |
| P160021S050 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2026-02-05 |
| P120003S009 | iCast Covered Stent System | Atrium Medical Corp. | 2025-12-22 |
| P160021S048 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2025-11-24 |
| P160021S049 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2025-10-17 |
| P160024S014 | LifeStream™ Balloon Expandable Vascular Covered Stent | Bard Peripheral Vascular, Inc. | 2025-09-29 |
| P120003S011 | iCast Covered Stent System | Atrium Medical Corp. | 2025-09-12 |
| P120003S010 | iCast Covered Stent System | Atrium Medical Corp. | 2025-08-20 |
| P120003S006 | iCast Covered Stent System | Atrium Medical Corp. | 2025-07-07 |
| P160021S047 | Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device) | W. L. Gore & Associates, Inc. | 2025-05-20 |
| P120003S008 | iCast Covered Stent System | Atrium Medical Corp. | 2025-05-01 |
| P160024S013 | LifeStream Balloon Expandable Vascular Covered Stent | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| P120003S005 | iCast Covered Stent System | Atrium Medical Corp. | 2024-08-07 |
| P120003S004 | iCast Covered Stent System | Atrium Medical Corp. | 2024-07-24 |
| P160021S045 | GORE VIABAHN VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2024-06-27 |
| P160021S046 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2024-06-18 |
| P160021S044 | GORE VIABAHN VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2024-06-04 |
| P160021S043 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2024-04-02 |
| P160021S042 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2024-03-27 |
| P160021S039 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2023-11-15 |
| P120003S003 | iCast Covered Stent System | Atrium Medical Corp. | 2023-10-18 |
| P120003S002 | iCast Covered Stent System | Atrium Medical Corp. | 2023-09-12 |
| P160021S040 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2023-07-13 |
| P120003S001 | iCast Covered Stent System | Atrium Medical Corp. | 2023-07-12 |
| P160021S041 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2023-07-05 |
| P160021S038 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2023-04-24 |
| P120003 | iCast Covered Stent System | Atrium Medical Corp. | 2023-03-22 |
| P160021S037 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2023-03-16 |
| P160021S036 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | 2022-12-21 |
| P160024S012 | LifeStream® Balloon Expandable Vascular Covered Stent | Bard Peripheral Vascular, Inc. | 2022-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00650862122923 | iCast covered stent system, 12mm x 29mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862720594 | iCast covered stent system, 10mm x 59mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862489323 | iCast covered stent system, 9mm x 32mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862488326 | iCast covered stent system, 8mm x 32mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862487329 | iCast covered stent system, 7mm x 32mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862486322 | iCast covered stent system, 6mm x 32mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862485325 | iCast covered stent system, 5mm x 32mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862480597 | iCast covered stent system, 10mm x 59mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862429329 | iCast covered stent system, 9mm x 32mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862427325 | iCast covered stent system, 7mm x 32mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862426328 | iCast covered stent system, 6mm x 32mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862425321 | iCast covered stent system, 5mm x 32mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862126129 | iCast covered stent system, 12mm x 61mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862126112 | iCast covered stent system, 12mm x 61mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862124125 | iCast covered stent system, 12mm x 41mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862124118 | iCast covered stent system, 12mm x 41mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862122916 | iCast covered stent system, 12mm x 29mm x 80cm | Atrium Medical Corporation | 2026-02-18 |
| 00650862428322 | iCast covered stent system, 8mm x 32mm x 120cm | Atrium Medical Corporation | 2026-02-18 |
| 00733132658367 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658350 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658343 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658336 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658329 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658312 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658305 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658299 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658282 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658275 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658268 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |
| 00733132658251 | GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates, Inc. | 2023-12-11 |