Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
FDA premarket approval P100018/S033 · decided 2021-07-27
Approval details
- PMA number
- P100018
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2021-07-12
- Decision date
- 2021-07-27
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- 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.
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