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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 NamePulseRider Aneurysm Neck Reconstruction Device
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
PULSAR VASCULAR, INC
130 knowles drive
suite e
san jose, CA 95131
HDE NumberH160002
Date Received06/15/2016
Decision Date06/19/2017
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number 17M-3839
Notice Date 06/23/2017
Advisory Committee Neurology
Clinical Trials NCT02312856
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Pulserider is indicated for use with neurovascular embolic coils in patients greater or equal to 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths greater than or equal to 4 mm or dome to neck ratio < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery. The inflow vessels should have diameters from 2. 7 mm to 4. 5 mm.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 
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