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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameCERENOVUS ENTERPRISE 2 Vascular Reconstruction Device and Delivery System
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International, SARL
chemin-blanc 38
le locle 2400
HDE NumberH060001
Supplement NumberS024
Date Received12/07/2021
Decision Date01/06/2022
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Modification of an in-process cleaning step of the core wire component from batch degreasing with trichloroethylene to vacuum degreasing with an alcohol-based solvent.
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