Valiant Navion Thoracic Stent Graft System
FDA premarket approval P100040/S036 · decided 2018-10-19
Approval details
- PMA number
- P100040
- Supplement
- S036
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Valiant Navion Thoracic Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2018-04-23
- Decision date
- 2018-10-19
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval of the Valiant Navion Thoracic Stent Graft System, a modified device design from the Valiant Thoracic Stent Graft with Captivia Delivery System. This device is indicated for all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;2) nonaneurysmal aortic diameter in the range of: 16 mm to 42 mm for fusiform and saccular aneurys
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