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Trade Name | Neuroform Atlas® Stent System |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H020002 |
Supplement Number | S059 |
Date Received | 09/20/2022 |
Decision Date | 10/18/2022 |
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 a change to the in-process specification of the inner diameter of the nitinol stent component of the neuroform atlas stent system. |