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 Number: 2029214
• FEI Number: 1000220862
• Name: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9775 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 Number: 3015550451
• FEI Number: 3015550451
• Name: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5290 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	Device	Date
PMA P100018S037 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
PMA P100018S036 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline™ Flex Embolization , Pipeline™ Flex Embolization with Shield Technology™	2021-12-27
PMN K211990 Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular	Rist 071 Radial Access Guide Catheter	2021-07-27
PMA P100018S033 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline Flex Embolization and Pipeline Flex Embolization with Shield Technology	2021-07-27
PMA P100018S032 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline Flex Embolization with Shield Technology	2021-07-19
PMN K203432 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Axium Detachable Coil; Axium Prime Detachable Coil	2021-07-07
PMN K203358 Micro Therapeutics, Inc D/b/a Ev3 Neurovascular	Solitaire X Revascularization Device	2021-03-01
PMA P100018S031 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline Flex Embolization	2021-02-26
PMN K202850 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Concerto Versa, Detachable Coil	2021-02-09
PMA P100018S030 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline Flex Embolization	2020-12-21
PMA P100018S028 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline Flex Embolization	2020-09-21
PMN K202318 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Marathon Flow Directed Micro Catheter	2020-09-14
PMN K201690 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire	2020-07-21
PMA P100018S027 Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR	Pipeline Flex Embolization	2020-06-29
OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Pipeline Vantage Embolization Device with Shield Technology	2020-02-27
OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Pipeline Vantage Embolization Device with Shield Technology	2020-02-27
OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Pipeline Flex Embolization Device with Shield Technology	2020-02-27
OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Pipeline Flex Embolization Device with Shield Technology	2020-02-27
PMN K193548 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire	2020-01-18
PMN K162539 | POL MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Solitaire? Platinum Revascularization Device	2019-07-23
PMN K162539 | POL MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Solitaire? Platinum Revascularization Device	2019-07-23
PMN K162539 | NRY MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Solitaire? Platinum Revascularization Device	2019-07-23
PMN K162539 | NRY MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Solitaire? Platinum Revascularization Device	2019-07-23
PMN K180959 | KRA MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K180959 | KRA MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K180959 | DQY MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K180959 | DQY MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K151638 | KRA MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K151638 | KRA MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K151638 | DQY MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K151638 | DQY MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR [MEDTRONIC INC.]	Phenom	2019-05-21
PMN K181807 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)	2019-03-06
PMN K183022 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Solitaire 4 Revascularization Device	2019-01-29
PMN K183185 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Riptide Aspiration System (Riptide Large Bore Aspiration System)	2018-12-18
PMN K182101 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Riptide Aspiration System (React 71 Catheter)	2018-11-14
PMN K182097 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	React 71 Catheter	2018-11-14
PMN K181186 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Solitare Platinum Revascularization Device	2018-10-25
PMN K180715 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	React 68 Catheter	2018-07-04
PMN K180705 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Riptide Aspiration System React 68 Catheter	2018-07-04
PMN K172448 Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular	Riptide Aspiration System	2017-12-21
PMN K160641 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Solitaire Platinum Revascularization Device, 6x40 Mm	2017-03-08
PMN K162704 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Axium Prime Detachable Coil System	2017-01-03
PMN K162539 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	Solitaire 2 Revascularization Device	2016-11-10
PMN K161152 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	Navien Intracranial Support Catheter	2016-10-12
PMN K161879 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Solitaire Platinum Revascularization Device	2016-09-21
PMN K153071 Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular	Solitaire Platinum Revascularization Device	2015-12-23
PMN K150107 MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR	Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter	2015-07-29
PMN K151447 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	Axium Detachable Coil System	2015-07-28
PMN K141516 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE	2015-02-05
PMN K141491 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	SOLITAIRE 2 REVASCULARIZATION DEVICE	2014-10-22
PMN K133310 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	AXIUM DETACHABLE COIL SYSTEM	2014-01-10

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• MicroTherapeutics, Inc. D/b/a Ev3 Neurovascular