PMA P180027S013

Device: Flow Re-Direction Endoluminal Device (FRED®) System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S013
Product code: OUT
Decision date: 2025-11-02
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval for the addition of the stent surface functionalization manufacturing process and to perform stent pusher loading, packaging, labeling, and sterilization on the FRED X system at the MicroVention Costa Rica manufacturing site located at Zona Franca Coyol Alajuela, Costa Rica.

Current openFDA PMA Record#

Device: Flow Re-Direction Endoluminal Device (FRED®) System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S013
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2025-11-02
Decision code: APPR
Date received: 2025-05-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of the stent surface functionalization manufacturing process and to perform stent pusher loading, packaging, labeling, and sterilization on the FRED X system at the MicroVention Costa Rica manufacturing site located at Zona Franca Coyol Alajuela, Costa Rica.