PMA P180027S004
- Device
- Flow Re-Direction Endoluminal Device (FRED) System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S004
- Product code
- OUT
- Decision date
- 2021-05-25
- Generic name
- Intracranial aneurysm flow diverter
- 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.
Current openFDA PMA Record#
- Device
- Flow Re-Direction Endoluminal Device (FRED) System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S004
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-05-25
- Decision code
- OK30
- Date received
- 2021-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.