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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecatheter, neuro-vasculature, occluding balloon
Generic Namecatheter, neuro-vasculature, occluding balloon
Regulation Number882.5150
2000 ringwood ave
san jose, CA 95131
HDE NumberH030005
Date Received09/05/2003
Decision Date03/30/2005
Product Code
Docket Number 05M-0132
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Indicated for the treatment of cerebral ischemia resulting from symptomaticvasospasm following aneurismal subarachnoid hemorrhage, secured by eithersurgical or endovascular intervention for patients who have failed maximalmedical management.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003