Ev3 Neurovascular

FDA Filings

This page includes the latest FDA filings for Ev3 Neurovascular. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P030004S027 EV3 NEUROVASCULAR	Onyx™ Liquid Embolic System	2021-09-16
PMA P030004S028 EV3 NEUROVASCULAR	Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm	2021-09-14
PMA P030004S026 EV3 NEUROVASCULAR	Apollo Onyx Delivery Micro Catheter	2021-03-18
PMA P030004S025 EV3 NEUROVASCULAR	Onyx Liquid Embolic System	2020-11-13
PMA P030004S024 EV3 NEUROVASCULAR	Apollo Onyx Delivery Micro Catheter	2020-06-29
PMA P030004S023 EV3 NEUROVASCULAR	Apollo Onyx Delivery Micro Catheter	2020-02-28
PMA P030004S022 EV3 NEUROVASCULAR	Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter	2019-12-19
PMA P030004S021 EV3 NEUROVASCULAR	Apollo Onyx Delivery Microcatheter	2019-12-10
PMA P030004S020 EV3 NEUROVASCULAR	Onyx Liquid Embolic System	2019-07-24
PMA P030004S019 EV3 NEUROVASCULAR	Onyx Liquid Embolic System	2019-06-17
PMA P030004S018 EV3 NEUROVASCULAR	Onyx Liquid Embolic System	2019-06-06
PMA P030004S016 EV3 NEUROVASCULAR	Apollo Onyx Delivery Micro Catheter	2018-12-27
PMA P030004S015 EV3 NEUROVASCULAR	Onyx Liquid Embolic System	2018-06-06
PMA P030004S014 EV3 NEUROVASCULAR	Onyx Liquid Embolic System	2018-02-06
PMA P030004S013 EV3 NEUROVASCULAR	Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight	2017-10-17
PMA P030004S012 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2017-01-25
PMA P030004S011 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2016-09-20
PMA P030004S010 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2016-03-31
PMA P030004S009 EV3 NEUROVASCULAR	ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR	2015-12-18
PMA P030004S006 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2014-05-27
PMA P030004S008 EV3 NEUROVASCULAR	ONYX 18LES & ONYX 34 LES	2013-10-09
PMA P030004S007 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM (LES)	2013-07-19
PMA P030004S005 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2012-04-05
PMN K093681 EV3 NEUROVASCULAR	MERIDIAN GUIDEWIRE	2010-01-26
PMN K091458 EV3 NEUROVASCULAR	HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104	2009-10-15
PMN K092495 EV3 NEUROVASCULAR	HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315	2009-09-22
PMA P030004S003 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2007-10-09
PMA P030004S002 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2006-11-29
PMA P030004S001 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2006-06-22
PMA P030004 EV3 NEUROVASCULAR	ONYX LIQUID EMBOLIC SYSTEM	2005-07-21

Similar & Related FDA Registered Companies

• EV3 NEUROVASCULAR9775 Toledo Wayirvine, CA 92618 PMA NumberP030004 Supplement NumberS029 Date Received06/29/2022 Decision Date07/28/2022 Product Code MFE  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No