Pipeline Flex Embolization Device
FDA premarket approval P100018/S023 · decided 2019-09-20
Approval details
- PMA number
- P100018
- Supplement
- S023
- 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
- 2019-08-22
- Decision date
- 2019-09-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Changes to the packaging operations of the Pipeline Flex Embolization Device, including the addition of a new pouch heat sealer and replacing quality control visual inspections with equivalent in-line inspections.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.