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Trade Name | PulseRider Aneurysm Neck Reconstruction Device |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Medos International, SARL |
chemin-blanc 38 |
le locle neuchatel CH 24 |
|
HDE Number | H160002 |
Supplement Number | S010 |
Date Received | 02/03/2020 |
Decision Date | 04/17/2020 |
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 a manufacturing site located at codman & shurtleff, inc. D/b/a depuy synthes products, inc. , 47709 fremont boulevard, fremont, california 94538, for the assembly, packaging and labeling of the pulserider aneurysm neck reconstruction device and the pulserider detachment system. |