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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 & ENTERPRISE 2 Vascular Reconstruction Devices and Delivery System
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International SARL
chemin-blanc 38
le locle 2400
HDE NumberH060001
Supplement NumberS023
Date Received12/26/2018
Decision Date01/25/2019
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 
Transfer the pre-sterilization quality control activities for the codman enterprise® and enterprise® vascular reconstruction devices and delivery systems from the codman raynham, ma site to other approved sites and to remove a redundant quality test (pre-sterilization one-piece inspection) from the receiving inspection (ri) procedure (codman raynham, ma).
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