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Trade Name | NEUROFORM MICRODELIVERY 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 | S038 |
Date Received | 09/23/2013 |
Decision Date | 10/23/2013 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updating the labeling procedure to specify that the scrapped labels are not to be reprinted without using the reprint form att06776, and 100% of the labels (pouch and carton) are to be checked for critical information including batch number, upn, sizeinformation before application. |