- Device
- Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S053
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2026-05-15
- Decision code
- OK30
- Date received
- 2026-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the relocation of the Pipeline Flex and Pipeline Shield heat treatment and passivation operations from an ISO 8 Controlled Environment Area (CEA) to a Non-Controlled Area (Non-CEA) and the repositioning of the Pipeline implant braider within the Non-CEA