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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 Vascular Reconstruction Device and Delivery System, CERENOVUS ENTERPRISE 2 Vascular Reconstruction
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International SARL
chemin-blanc 38
le locle 2400
HDE NumberH060001
Supplement NumberS026
Date Received11/13/2023
Decision Date12/08/2023
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 
Approval for packaging process changes for the enterprise and enterprise 2 vascular reconstruction devices and delivery system, including reduction of pouch seal testing, elimination of redundant quality control inspections, and combination of pouch sealing and boxing operations into a continuous flow operation.
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