|
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 | S004 |
Date Received | 05/03/2021 |
Decision Date | 05/25/2021 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Conversion of a two-step UV glue process into a 1-step UV glue process for the Flow Re-Direction Endoluminal Device (FRED) System. |