Pipeline Flex Embolization Device (Pipeline Flex); Pipeline Flex Embolization Device with Shield Technology (Pipelin
FDA premarket approval P100018/S053 · decided 2026-05-15
Approval details
- PMA number
- P100018
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device (Pipeline Flex); Pipeline Flex Embolization Device with Shield Technology (Pipelin
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2026-04-17
- Decision date
- 2026-05-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- 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
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