PMA P030004S012

Device: ONYX LIQUID EMBOLIC SYSTEM
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S012
Product code: MFE
Decision date: 2017-01-25
Classification: Agent, Injectable, Embolic
Generic name: Agent, injectable, embolic
Approval order statement: Acceptance for manufacturing equipment/process changes related to the production of the Onyx Liquid Embolic System (LES), which include addition of an alternative cleaning and de-pyrogenation method for the Onyx LES, addition of an alternative dry heat sterilization oven for the Onyx LES, and change of bioburden testing lab for the Onyx vial subassembly.

Current openFDA PMA Record#

Device: ONYX LIQUID EMBOLIC SYSTEM
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S012
Product code: MFE
Generic name: Agent, injectable, embolic
Decision date: 2017-01-25
Decision code: OK30
Date received: 2016-12-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Acceptance for manufacturing equipment/process changes related to the production of the Onyx Liquid Embolic System (LES), which include addition of an alternative cleaning and de-pyrogenation method for the Onyx LES, addition of an alternative dry heat sterilization oven for the Onyx LES, and change of bioburden testing lab for the Onyx vial subassembly.