PMA P030004S016

Device

Apollo Onyx Delivery Micro Catheter

Applicant

Ev3 Neurovascular

PMA number

P030004

Supplement

S016

Product code

MFE

Decision date

2018-12-27

Classification

Agent, Injectable, Embolic

Generic name

Agent, injectable, embolic

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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