|
Trade Name | LVIS INTRALUMINAL SUPPORT DEVICE |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Micro Vention, Inc. |
1311 valencia avenue |
tustin, CA 92780 |
|
HDE Number | H130005 |
Supplement Number | S004 |
Date Received | 12/19/2016 |
Decision Date | 03/03/2017 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement A 4. 0 mm nominal device size which falls with the currently approved range of 3. 5 mm to 5. 5 mm device sizes. |