FDA-Device2023-11-22Class II
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Atrium Medical Corporation
Hazard
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Sold states
Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Affected count
141 units
Manufactured in
40 Continental Blvd, N/A, Merrimack, NH, United States
Products
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2024Don't want to check this manually?
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