Pipeline Flex Embolization Device
FDA premarket approval P100018/S016 · decided 2017-10-11
Approval details
- PMA number
- P100018
- Supplement
- S016
- 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
- 2017-09-14
- Decision date
- 2017-10-11
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change to the hypotube manufacturing process of a sub tier supplier in order to improve overall component yield and reduce scrap.
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