PMA P180027S010

Device: FRED
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S010
Product code: OUT
Decision date: 2024-01-17
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval for manufacturing site change for the component supplier that winds platinum wire into coils for the distal tip of the delivery system pusher of the Flow Re-Direction Endoluminal Device (FRED) System and Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., and LVIS EVO

Current openFDA PMA Record#

Device: FRED
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S010
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-01-17
Decision code: OK30
Date received: 2023-12-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for manufacturing site change for the component supplier that winds platinum wire into coils for the distal tip of the delivery system pusher of the Flow Re-Direction Endoluminal Device (FRED) System and Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., and LVIS EVO