Pipeline Flex Embolization Device
FDA premarket approval P100018/S028 · decided 2020-09-21
Approval details
- PMA number
- P100018
- Supplement
- S028
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pipeline Flex Embolization Device
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2020-08-24
- Decision date
- 2020-09-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for labeling changes to the instructions for use to strengthen information about possible device component separation, fracture, or breakage in the warnings, cautions and potential complications sections.
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