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Trade Name | CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System, CERENOVUS ENTERPRISE 2 Vascular Reconstruction |
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 | S026 |
Date Received | 11/13/2023 |
Decision Date | 12/08/2023 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |