PMA P100018S020

Device: Pipeline Flex Embolization Device
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S020
Product code: OUT
Decision date: 2019-05-22
Classification: Intracranial Aneurysm Flow Diverter
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Upgrades to the laser equipment used to form the distal tip of the introducer sheath of the Pipeline Flex Embolization device.

Current openFDA PMA Record#

Device: Pipeline Flex Embolization Device
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S020
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2019-05-22
Decision code: OK30
Date received: 2019-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Upgrades to the laser equipment used to form the distal tip of the introducer sheath of the Pipeline Flex Embolization device.