Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield); Pipeline Vantage Embolization Device wit
FDA premarket approval P100018/S054 · decided 2026-06-26
Approval details
- PMA number
- P100018
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield); Pipeline Vantage Embolization Device wit
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2026-05-28
- Decision date
- 2026-06-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- approval to remove the X-ray Photelectron Spectroscopy (XPS) testing and its associated Statistical Process Control (SPC) recording for the application of Shield Technology to the Pipeline braid and additional enhanced process controls, including minimum fill height verification and the addition of a 9 mm guard band
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