Product code MIH
- Device name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- 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
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P180001S017 | Zenith Fenestrated AAA Endovascular Graft | William Cook Europe Aps | 2026-05-21 |
| P140016S017 | Zenith Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System | Cook Medical Incorporated | 2026-05-21 |
| P020018S068 | Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular Graft | Cook, Inc. | 2026-05-21 |
| P200030S024 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | 2026-05-14 |
| P020004S205 | GORE® EXCLUDER® AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2026-05-14 |
| P100021S132 | Endurant™ II/IIs Stent Graft System | Medtronic Vascular | 2026-05-12 |
| P180001S016 | Zenith Dissection Endovascular System | William Cook Europe Aps | 2026-05-08 |
| P140016S016 | Zenith Alpha Thoracic Endovascular Graft | Cook Medical Incorporated | 2026-05-08 |
| P020004S206 | GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | 2026-04-28 |
| P020018S067 | Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith Flex with Spi | Cook, Inc. | 2026-04-21 |
| P200045S017 | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 2026-04-13 |
| P190015S024 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 2026-04-13 |
| P190015S026 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 2026-03-26 |
| P210032S025 | GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | W. L. Gore & Associates, Inc. | 2026-03-09 |
| P040043S149 | GORE® TAG® Conformable Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. | 2026-03-09 |
| P040043S148 | GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | W. L. Gore & Associates, Inc. | 2026-03-09 |
| P020018S066 | Zenith Flex AAA Endovascular System and Zenith Iliac Branch | Cook, Inc. | 2026-03-09 |
| P100040S074 | Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System | Medtronic Vascular | 2026-02-27 |
| P100021S134 | Endurant™, Endurant™ II/lls Stent Graft System | Medtronic Vascular | 2026-02-27 |
| P200045S022 | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 2026-02-19 |
| P190015S029 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 2026-02-19 |
| P190015S027 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 2026-02-18 |
| P100021S133 | Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System | Medtronic Vascular | 2026-01-27 |
| P200030S023 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | 2025-12-05 |
| P100021S131 | Endurant II/IIs Stent Graft System | Medtronic Vascular | 2025-10-23 |
| P210032S024 | GORE® TAG® Thoracic Branch Endoprosthesis | W. L. Gore & Associates, Inc. | 2025-10-17 |
| P040043S147 | GORE® TAG® Conformable Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. | 2025-10-15 |
| P110038S033 | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | Bolton Medical, Inc. | 2025-10-10 |
| P020004S204 | GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | 2025-10-09 |
| P200045S018 | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 2025-10-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132610211 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610549 | GORE EXCLUDER AAA Endoprosthesis with C3 Delivery | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610532 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610525 | GORE EXCLUDER AAA Endoprosthesis with C3 Delivery | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610518 | GORE EXCLUDER AAA Endoprosthesis with C3 Delivery | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610358 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610341 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610334 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610303 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610297 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610273 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610266 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610259 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610235 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610228 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610204 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610198 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610181 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610174 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610167 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610150 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610143 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610136 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610129 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610112 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610105 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610099 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132610068 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2015-11-27 |
| 00733132610082 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2015-11-27 |
| 00733132610075 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2015-11-27 |