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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 |
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HDE Number | H020002 |
Supplement Number | S058 |
Date Received | 01/12/2022 |
Decision Date | 01/26/2022 |
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 Three changes to the non-patient contacting introducer sheath component of the neuroform atlas stent system: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; 3) tip length specification simplification and change of the nominal length. |