Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. |
Generic Name | Intracranial coil-assist stent |
Applicant | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
PMA Number | P170013 |
Supplement Number | S003 |
Date Received | 11/24/2020 |
Decision Date | 02/25/2021 |
Product Code |
QCA |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at MicroVention, Inc., 35 Enterprise, Aliso Viejo, California 92656. |
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