Pipeline Flex Embolization Device (PFED)
FDA premarket approval P100018/S017 · decided 2018-06-15
Approval details
- PMA number
- P100018
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pipeline Flex Embolization Device (PFED)
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2017-12-15
- Decision date
- 2018-06-15
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modifications to the device labeling to include a summary of the long-term follow-up results of the Pipeline for Uncoilable or Failed Aneurysms - Post Approval Study (PUFS-PAS).
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