PMA P100018S015
- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S015
- Product code
- OUT
- Decision date
- 2018-12-14
- Classification
- Intracranial Aneurysm Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval for the Pipeline Flex Embolization Device to expand the indications for use to include use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 5.0 mm.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100018S015B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S015
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2018-12-14
- Decision code
- APPR
- Date received
- 2017-06-28
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Pipeline Flex Embolization Device to expand the indications for use to include use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and