|
Device | Flow Re-Direction Endoluminal Device (FRED®) System |
Generic Name | Intracranial aneurysm flow diverter |
Applicant | MicroVention, Inc. 35 Enterpricse Aliso Viejo, CA 92656 |
PMA Number | P180027 |
Supplement Number | S002 |
Date Received | 03/30/2021 |
Decision Date | 09/16/2021 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the FRED X System that contains a novel polymer surface treatment on the neurovascular flow-diverting stent. |
Post-Approval Study | Show Report Schedule and Study Progress |