|
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 | S005 |
Date Received | 04/05/2017 |
Decision Date | 05/10/2017 |
Product Code | |
Advisory Committee |
Neurology |
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 a modification to the directions for use (dfu) regarding the magnetic resonance imaging (mri) conditional information. In addition, you provided the supporting performance testing to support the changes to the mri conditional information in the dfu. |