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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 NameCODMAN ENTERPRISE VASCULAR RECONSTRUCTIVE 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 NumberS021
Date Received08/23/2016
Decision Date09/21/2016
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 
Acceptance for implementation of a clean room move within the same facility at specialty coating systems, inc. And to expand coating capacity through the addition of two duplicate parylene c coaters.
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