PMA P180027S007

Device: Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S007
Product code: OUT
Decision date: 2022-03-01
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Relocation of the supplier of several Flow Re-Direction Endoluminal Device (FRED) System and FRED X System components, Creganna Medical, from the manufacturing location in Tualatin, Oregon, to Wilsonville, Oregon, and Heredia, Costa Rica.

Current openFDA PMA Record#

Device: Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S007
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2022-03-01
Decision code: OK30
Date received: 2022-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the supplier of several Flow Re-Direction Endoluminal Device (FRED) System and FRED X System components, Creganna Medical, from the manufacturing location in Tualatin, Oregon, to Wilsonville, Oregon, and Heredia, Costa Rica.