System, Endovascular Graft, Aortic Aneurysm Treatment
Basic Information
- Device Name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Trade Name
- RelayPro Thoracic Stent-Graft System
- PMA Number
- P200045
- Device Class
- FDA Class 3
- Product Code
- MIH
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 5, 2021
- Date Received
- November 20, 2020
- Expedited Review
- N
- Docket Number
- 21M-0805
Advisory Committee Statement
Approval for The Relay®Pro Thoracic Stent-Graft System. The device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:-- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;-- Non-aneurysmal aortic neck diameter in the range of 20 to 42 mm; and -- Non-aneurysmal proximal aortic neck lengths of: 15 mm for the 24 to 28 mm Bare Stent Configuration device diameters 20 mm for the 30 to 38 mm Bare Stent Configuration device diameters 25 mm for the 40 to 46 mm Bare Stent Configuration device diameters 25 mm for the 24 to 38 mm Non-Bare Stent Configuration device diameters 30 mm for the 40 to 46 mm Non-Bare Stent Configuration device diameters Non-aneurysmal distal aortic neck lengths of: 25 mm for the 24 to 38 mm device diameters 30 mm for the 40 to 46 mm device diameters.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | FDA class 3 | Unknown |