Pipeline Flex Embolization Device
FDA premarket approval P100018/S030 · decided 2020-12-21
Approval details
- PMA number
- P100018
- Supplement
- S030
- 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
- 2020-11-27
- Decision date
- 2020-12-21
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- implementation of a statistical process monitoring control limit for the Pipeline Flex Embolization Device proximal delivery system hypotube subassembly
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