Pipeline Flex Embolization Device with Shield Technology (PED2), Pipeline Vantage Embolization Device with Shield Tec
FDA premarket approval P100018/S044 · decided 2024-04-25
Approval details
- PMA number
- P100018
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pipeline Flex Embolization Device with Shield Technology (PED2), Pipeline Vantage Embolization Device with Shield Tec
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2024-01-26
- Decision date
- 2024-04-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- approval for labeling changes [Directions for Use and Magnetic Resonance Imaging (MRI) Card] to the Pipeline Flex Embolization Device with Shield Technology and Pipeline Vantage Embolization Device with Shield Technology to incorporate more comprehensive MRI safety information
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