|
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 | S003 |
Date Received | 05/29/2015 |
Decision Date | 06/08/2016 |
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 Aproval to increase the density of the wire braid pattern of the lvis 3. 5, 4. 5, and 5. 5 mm size stents to minimize deployment variability. |