- Device
- Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S033
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-07-27
- Decision code
- OK30
- Date received
- 2021-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to hypotube tensile strength test of Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, using an in-process manufacturing acceptance criteria of >= 3.0 N for the test, and shifting the hypotube tensile strength test from the final inspection step to an earlier subassembly step.