|
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 | S003 |
Date Received | 05/29/2018 |
Decision Date | 06/15/2018 |
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 Revision to the production process flow to create separate process steps for the manufacture of a specific subassembly. |