Pipeline Flex Embolization Device
FDA premarket approval P100018/S024 · decided 2020-10-05
Approval details
- PMA number
- P100018
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Pipeline Flex Embolization Device
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2020-03-10
- Decision date
- 2020-10-05
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for labeling changes to incorporate completed results from the post-approval study (PAS) titled Prospective Study on Embolization of Intracranial Aneurysms with Pipeline Embolization Device (PREMIER).
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