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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.
 
Trade NameCOAXIA NEUROFLO CATHETER
Classification Namecatheter, neuro-vasculature, occluding balloon
Generic Namecatheter, neuro-vasculature, occluding balloon
Regulation Number882.5150
Applicant
ZOLL CIRCULATION
2000 ringwood ave
san jose, CA 95131
HDE NumberH030005
Date Received09/05/2003
Decision Date03/30/2005
Product Code
PAV[ Registered Establishments with PAV ]
Docket Number 05M-0132
Advisory Committee Neurology
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 
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