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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 | S001 |
Date Received | 08/18/2014 |
Decision Date | 10/08/2014 |
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 Approval for the addition of four models of the lvis jr device thathave an unconstrained diameter of 2. 5. Mm, and the addition of the scepter c and xc balloon delivery catheters for use with these models. |