Pipeline Flex Embolization Device
FDA premarket approval P100018/S021 · decided 2019-07-15
Approval details
- PMA number
- P100018
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2019-07-05
- Decision date
- 2019-07-15
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Manufacturing facility relocation at a metal wire critical component supplier.
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