FDA-Device2021-02-17Class I
EMBLEM S-ICD Model A209
Boston Scientific Corporation
Hazard
Electrical overstress may lead to device malfunction.
Sold states
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Affected count
1953 units
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
EMBLEM S-ICD Model A209
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0950-2021Don't want to check this manually?
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