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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 NameENTERPRISE™ and ENTERPRISE™ 2 Vascular Reconstruction Device and Delivery Systems
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International SARL
chemin-blanc 38
le locle 2400
HDE NumberH060001
Supplement NumberS025
Date Received11/23/2022
Decision Date02/06/2023
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for manufacturing sites located at: • steris isomedix services, 1175 isuzu parkway, grand prairie, texas, 75050, • steris isomedix services, 7685 st. Andrews avenue, san diego, california, 92154, and • sterigenics, 2400 airport road, santa teresa, new mexico, 88008. These manufacturing sites will be performing sterilization of the enterprise and enterprise 2 vascular reconstruction device and delivery system.
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