A meeting of the Circulatory System Devices Panel was held on April 10, 2003. The Panel discussed, made recommendations, and voted on a premarket approval application (P020018) for the Zenith AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System and ancillary components.
The device is indicated for the endovascular treatment of patients with abdominal aortic, aortoiliac or iliac aneurysms having morphology suitable for endovascular repair, including:
- Adequate iliac/femoral access (7.5 mm)
- Non-aneurysmal infrarenal neck length of at least 15 mm
- Neck diameter measured outer wall to outer wall of no greater than 28 mm and no less than 18 mm
- Iliac artery distal fixation site greater than 10 mm in length and no greater than 20 mm in diameter (measured outer wall to outer wall)
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (8-0) that the application be found ‘approvable with conditions’. The Panel’s conditions included revisions to the Intended Use of the device, removing references to isolated iliac aneurysm from the indications for use, stressing the importance in the labeling of lifelong clinical follow up of patients following endograft placement, and a post approval study as outlined in the PMA for follow up of patients in the pivotal study for 5 years. The panel also recommended modifications to the device labeling.
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.