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 |
|---|---|---|---|
| P180001S018 | Zenith Dissection Endovascular System (ZDEG/ZDES) | William Cook Europe Aps | 2026-08-04 |
| P140016S018 | Zenith Alpha/ Alpha 2 Thoracic Endovascular Graft (ZTA/ZTA2) | Cook Medical Incorporated | 2026-08-04 |
| P020018S069 | Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch (ZBIS) | Cook, Inc. | 2026-08-04 |
| P200030S026 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | 2026-07-29 |
| P210032S026 | GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 | W. L. Gore & Associates, Inc. | 2026-07-13 |
| P200030S025 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | 2026-07-08 |
| P020004S207 | GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | 2026-07-08 |
| P020004S208 | GORE® EXCLUDER® AAA Endoprosthesis | W. L. Gore & Associates, Inc. | 2026-06-23 |
| P200045S024 | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 2026-06-18 |
| P190015S030 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 2026-06-18 |
| P120006S045 | Alto Abdominal Stent Graft System | Endologix, LLC | 2026-06-03 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00843576150416 | RelayPro NBS Thoracic Stent-Graft System | Bolton Medical Inc. | 2023-04-24 |
| 00843576150362 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150508 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150492 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150485 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150478 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150461 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150454 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150447 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150430 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150423 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150409 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150393 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150386 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150379 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150218 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150355 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150348 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150331 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150324 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150317 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150300 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150294 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150287 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150270 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150263 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150256 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150249 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150232 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |
| 00843576150225 | RelayPro Thoracic Stent-Graft System | Bolton Medical Inc. | 2021-09-22 |