- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S030
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-12-21
- Decision code
- OK30
- Date received
- 2020-11-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a statistical process monitoring control limit for the Pipeline Flex Embolization Device proximal delivery system hypotube subassembly