|
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 | S004 |
Date Received | 09/12/2018 |
Decision Date | 03/25/2020 |
Product Code | |
Advisory Committee |
Neurology |
Clinical Trials |
NCT02312856
|
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the instructions for use document to include the 1-year results from the "adjunctive neurovascular support for wide-neck aneurysm embolization and reconstruction (answer)" clinical study. |