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. |
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Trade Name | ENTERPRISE™ and ENTERPRISE™ 2 Vascular Reconstruction Device and Delivery Systems |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Medos International, SARL |
chemin-blanc 38 |
le locle 2400 |
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HDE Number | H060001 |
Supplement Number | S025 |
Date Received | 11/23/2022 |
Decision Date | 02/06/2023 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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