PMA P100018S019

Device

Pipeline Flex Embolization Device

Applicant

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

PMA number

P100018

Supplement

S019

Product code

OUT

Decision date

2018-12-27

Classification

Intracranial Aneurysm Flow Diverter

Generic name

Intracranial aneurysm flow diverter

Approval order statement

Change to allow sterile product to be released based on parametric release, rather than conventional release at the contract sterilization site (Sterigenics US LLC).

Summary

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