Micro Therapeutics Inc D B A Ev3 Neurovascular

FDA Filings

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

FDA Registration(s)
Registration Number2029214
FEI Number1000220862
NameMICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9775 Toledo Way
Irvine, CA 92618 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only



Registration Number3015550451
FEI Number3015550451
NameMICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5290 California Avenue
Irvine, CA 92617 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR9775 Toledo Wayirvine, CA 92618 PMA NumberP100018 Supplement NumberS037 Date Received08/09/2022 Decision Date11/02/2022 Product Code OUT  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Pipeline™ Flex Embolization and Pipeline™ Flex Embolization with Shield Technology™2022-11-02
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline™ Flex Embolization , Pipeline™ Flex Embolization with Shield Technology™2021-12-27
Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular
Rist 071 Radial Access Guide Catheter2021-07-27
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline Flex Embolization and Pipeline Flex Embolization with Shield Technology2021-07-27
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline Flex Embolization with Shield Technology2021-07-19
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Axium Detachable Coil; Axium Prime Detachable Coil2021-07-07
Micro Therapeutics, Inc D/b/a Ev3 Neurovascular
Solitaire X Revascularization Device2021-03-01
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline Flex Embolization2021-02-26
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Concerto Versa, Detachable Coil2021-02-09
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline Flex Embolization2020-12-21
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline Flex Embolization2020-09-21
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Marathon Flow Directed Micro Catheter2020-09-14
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire2020-07-21
Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Pipeline Flex Embolization2020-06-29
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Pipeline Vantage Embolization Device with Shield Technology2020-02-27
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Pipeline Vantage Embolization Device with Shield Technology2020-02-27
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Pipeline Flex Embolization Device with Shield Technology2020-02-27
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Pipeline Flex Embolization Device with Shield Technology2020-02-27
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire2020-01-18
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Solitaire? Platinum Revascularization Device2019-07-23
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Solitaire? Platinum Revascularization Device2019-07-23
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Solitaire? Platinum Revascularization Device2019-07-23
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Solitaire? Platinum Revascularization Device2019-07-23
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]
Phenom2019-05-21
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)2019-03-06
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Solitaire 4 Revascularization Device2019-01-29
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Riptide Aspiration System (Riptide Large Bore Aspiration System)2018-12-18
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Riptide Aspiration System (React 71 Catheter)2018-11-14
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
React 71 Catheter2018-11-14
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Solitare Platinum Revascularization Device2018-10-25
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
React 68 Catheter2018-07-04
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Riptide Aspiration System React 68 Catheter2018-07-04
Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular
Riptide Aspiration System2017-12-21
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Solitaire Platinum Revascularization Device, 6x40 Mm2017-03-08
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Axium Prime Detachable Coil System2017-01-03
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
Solitaire 2 Revascularization Device2016-11-10
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
Navien Intracranial Support Catheter2016-10-12
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Solitaire Platinum Revascularization Device2016-09-21
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular
Solitaire Platinum Revascularization Device2015-12-23
MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter2015-07-29
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
Axium Detachable Coil System2015-07-28
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE2015-02-05
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SOLITAIRE 2 REVASCULARIZATION DEVICE2014-10-22
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
AXIUM DETACHABLE COIL SYSTEM2014-01-10

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