Atricure Inc

FDA Filings

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

USANASDAQATRCDUNS 006133784
FDA Registration(s)
Registration Number3011706110
FEI Number3011706110
NameATRICURE, INC.
Owner & OperatorATRICURE, INC.
Contact Address7555 Innovation Way --
Mason OH 45040 US
Official Correspondent
  • John S Ehlert
  • x-513-6448220-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7555 Innovation Way
Mason, OH 45040 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3011788769
FEI Number3011788769
NameAtriCure - Minneapolis
Owner & OperatorATRICURE, INC.
Contact Address7555 Innovation Way --
Mason OH 45040 US
Official Correspondent
  • John S Ehlert
  • x-513-6448220-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address130 Cheshire Ln Ste 250
Minnetonka, MN 55305 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3005802238
FEI Number3006482885
NameSENTREHEART INC.
Owner & OperatorATRICURE, INC.
Contact Address7555 Innovation Way --
Mason OH 45040 US
Official Correspondent
  • John S Ehlert
  • x-513-6448220-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address300 Saginaw Dr
Redwood City, CA 94063 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ATRICURE, INC.
AtriCure System Cart A0008422021-01-19
ATRICURE, INC.
nContact RF Generator CSK-3202021-01-19
ATRICURE, INC.
Synergy™ Ablation System A0004352021-01-19
ATRICURE, INC.
Isolator Surgical Ablation System A0004752021-01-19
ATRICURE, INC.
Isolator Surgical Ablation System A0004672021-01-19
ATRICURE, INC.
Isolator Surgical Ablation System A0004522021-01-19
ATRICURE, INC.
Dissector A0004182021-01-19
ATRICURE, INC.
AtriCure System Cart A0008432021-01-19
ATRICURE, INC.
Isolator Surgical Ablation System A0003182021-01-19
ATRICURE, INC.
Dissector A0001952021-01-19
ATRICURE, INC.
TenSURE FG-00172021-01-19
ATRICURE, INC.
SofTIP FG-00082021-01-19
ATRICURE, INC.
SureCUT FG-00062021-01-19
ATRICURE, INC.
Lariat RS FG-00282021-01-19
ATRICURE, INC.
EndoCATH FG-00032021-01-19
ATRICURE, INC.
Ablation Sensing Unit A0000492021-01-19
ATRICURE, INC.
nContact RF Generator 2021-01-19
ATRICURE, INC.
cryoICE BOX A0007282021-01-19
ATRICURE, INC.
cryoICE BOX A0007272021-01-19
ATRICURE, INC.
cryoICE Cryoablation System A0007082021-01-19
ATRICURE, INC.
nContact RF Generator 2021-01-19
ATRICURE, INC.
nContact RF Generator 2021-01-19
ATRICURE, INC.
FindrWIRZ FG-0052021-01-19
ATRICURE, INC.
AtriCure System Cart A0008032021-01-19
ATRICURE, INC.
AtriCure System Cart A0009512021-01-19
ATRICURE, INC.
AtriCure System Cart A0008352021-01-19
ATRICURE, INC.
cryoICE Cryoablation System A00898-32021-01-19
ATRICURE, INC.
AtriCure cryoICE cryoSPHERE Cryoablation System A0010122021-01-18
ATRICURE, INC.
AtriCure cryoICE cryoSPHERE Cryoablation System A0010092021-01-18
ATRICURE, INC.
AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) A0009572021-01-18
ATRICURE, INC.
cryoICE Cryoablation System A000957-62021-01-18
ATRICURE, INC.
AtriCure cryoICE Cryoablation System (CRYO3) A0009252021-01-18
ATRICURE, INC.
cryoICE Cryoablation System A0009252021-01-18
ATRICURE, INC.
AtriCure cryoICE Cryoablation System (CRYO2) A000683-62021-01-18
ATRICURE, INC.
cryoICE Cryoablation System A000683-22021-01-18
ATRICURE, INC.
Isolator Surgical Ablation System A0006252021-01-18
ATRICURE, INC.
Synergy™ Ablation System A0004322021-01-18
ATRICURE, INC.
Synergy™ Ablation System A0003622021-01-18
ATRICURE, INC.
Isolator Surgical Ablation System A0001632021-01-18
ATRICURE, INC.
Synergy™ Ablation System A0004372021-01-18
ATRICURE, INC.
Isolator Surgical Ablation System A0006782021-01-18
ATRICURE, INC.
Isolator Surgical Ablation System A000248 2021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0008272021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0008262021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0008252021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0008242021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006472021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006462021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006452021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006442021-01-18
ATRICURE, INC.
Fusion Ablation System A0012982021-01-18
ATRICURE, INC.
Fusion Ablation System A0012942021-01-18
ATRICURE, INC.
EPi-Sense Guided Coagulation System with VisiTrax 2021-01-18
ATRICURE, INC.
EPi-Sense Guided Coagulation System with VisiTrax A0012802021-01-18
ATRICURE, INC.
Subtle Cannula with Guide 2021-01-18
ATRICURE, INC.
Subtle Cannula with Guide 2021-01-18
ATRICURE, INC.
AtriClip® LAA Exclusion System A0003492021-01-18
ATRICURE, INC.
AtriClip® PRO•V™ LAA Exclusion System A0009742021-01-18
ATRICURE, INC.
AtriClip® PRO•V™ LAA Exclusion System A0009732021-01-18
ATRICURE, INC.
AtriClip® PRO•V™ LAA Exclusion System A0009722021-01-18
ATRICURE, INC.
AtriClip® PRO•V™ LAA Exclusion System A0009712021-01-18
ATRICURE, INC.
AtriClip® LAA Exclusion System A0009682021-01-18
ATRICURE, INC.
AtriClip® LAA Exclusion System A0009672021-01-18
ATRICURE, INC.
AtriClip® LAA Exclusion System A0009662021-01-18
ATRICURE, INC.
AtriClip® LAA Exclusion System A0009652021-01-18
ATRICURE, INC.
AtriClip FLEX•V A0010202021-01-18
ATRICURE, INC.
AtriClip FLEX•V A0010192021-01-18
ATRICURE, INC.
AtriClip FLEX•V A0010182021-01-18
ATRICURE, INC.
AtriClip FLEX•V A0010172021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0009192021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0009182021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0009172021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0009162021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006912021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006902021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006892021-01-18
ATRICURE, INC.
AtriClip™ LAA Exclusion System A0006882021-01-18
ATRICURE, INC.
Isolator Surgical Ablation System A0006022021-01-18
AtriCure Inc.
AtriCure CryoICE Cryo-ablation Probe (Cryo2), AAtriCure CryoICE CryoSPHERE Cryoablation Probe (CryoS, CryoS-L)2020-12-23
ATRICURE INC.
Synergy Ablation System2020-08-14
ATRICURE, INC.
AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) A000957-62020-03-26
ATRICURE, INC.
AtriCure cryoICE Cryoablation System (CRYO3) A000925-62020-03-26
ATRICURE, INC.
AtriCure cryoICE Cryoablation System (CRYO2) A000683-62020-03-26
ATRICURE, INC.
AtriCure Coolrail Linear Pen2020-02-28
ATRICURE, INC.
SofTIP 60022020-02-06
ATRICURE, INC.
EPi-Sense Guided Coagulation Device with VisiTrax2020-01-24
ATRICURE, INC.
Isolator pen2020-01-13
ATRICURE, INC.
AtriClip LAA Exclusion System2020-01-10
ATRICURE, INC.
AtriCure System Cart A0008192020-01-08
ATRICURE, INC.
cryoICE Cryoablation System A0007082020-01-08
ATRICURE, INC.
Synergy™ Ablation System A0004322020-01-08
ATRICURE, INC.
Synergy™ Ablation System A0003622020-01-08
ATRICURE, INC.
Synergy™ Ablation System A0000492020-01-08
ATRICURE, INC.
SureCUT 50012020-01-07
ATRICURE, INC.
Lariat 2020-01-07
ATRICURE, INC.
FindrWIRZ 40052019-12-31
ATRICURE, INC.
EndoCATH 20062019-12-31
ATRICURE, INC.
TenSURE 80022019-12-27
AtriCure, Inc.
EPi-Sense Guided Coagulation System With VisiTrax2019-12-13
ATRICURE, INC.
Isolator Surgical Ablation System A000475-42019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0006252019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0006022019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0004752019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0004672019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0004522019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0003182019-11-27
ATRICURE, INC.
Isolator Surgical Ablation System A0001632019-11-27
SENTREHEART INC. [ATRICURE, INC.]
LARIAT RS Suture Delivery Device2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
LARIAT RS Suture Delivery Device2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
LARIAT+ Suture Delivery Device2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
LARIAT+ Suture Delivery Device2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
LARIAT Suture Delivery Device; SofTIP Guide Cannula2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
LARIAT Suture Delivery Device; SofTIP Guide Cannula2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
FindrWirz Guide Wire System2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
EndoCATH Occlusion Balloon2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
TenSURE Suture Puller2019-11-07
SENTREHEART INC. [ATRICURE, INC.]
SureCUT Suture Cutter2019-11-07
AtriCure, Inc
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen2019-11-04
AtriCure, Inc
AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System With Preloaded V-Clip2019-08-21
AtriCure, Inc
Coolrail Linear Pen2019-07-24
ATRICURE INC.
AtriCure Synergy Ablation System2019-06-26
ATRICURE, INC.
COBRA Fusion Magnetic Retriever2019-03-14
ATRICURE, INC.
COBRA Fusion 50 Ablation System2019-03-14
ATRICURE, INC.
COBRA Fusion 150 Ablation System2019-03-14
ATRICURE, INC.
AtriCure Coolrail linear pen2019-03-13
AtriCure, Inc.
COBRA Fusion Ablation System2019-02-25
ATRICURE INC.
Synergy Ablation System2018-12-31
AtriCure, Inc.
Coolrail Linear Pen2018-12-04
ATRICURE, INC.
AtriCure cryoICE cryoSPHERE Cryoablation System2018-11-13
AtriCure, Inc.
AtriCure CryoICE CryoSPHERE Cryoablation Probe2018-11-09
ATRICURE, INC.
AtriClip LAA Exclusion System2018-07-17
AtriCure, Inc.
ArtiClip LAA Exclusion System2018-06-28
ATRICURE, INC.
AtriCure cryoICE cryo-ablation probe (CRYO2)2018-02-21
ATRICURE, INC.
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)2018-02-21
AtriCure, Inc.
AtriCure CryoICE Cryo-ablation Probe (CRYO2)2018-02-15
AtriCure, Inc.
AtriCure CryoICE Cryo-ablation Probe (CRYO3), AtriCure CryoICE CryoFORM Cryo-ablation Probe (CRYOF)2018-02-15
ATRICURE, INC.
AtriClip FLEX-V device2018-02-06
AtriCure, Inc.
AtriClip FLEX-V2018-01-31
AtriCure, Inc.
AtriClip LAA Exclusion System With Preloaded PRO·V Clip2017-10-25
AtriCure, Inc.
AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip (PRO2)2017-10-11
ATRICURE INC.
AtriClip PRO, PRO2, And PRO V LAA Exclusion System Devices With Preloaded Gillinov-Cosgrove Clip2017-05-19
AtriCure Inc.
Isolator Multifunctional Linear Pen2017-01-03
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2016-12-14
ATRICURE, INC.
EPi-Sense Guided Coagulation Device with VisiTrax2016-11-07
ATRICURE, INC.
EPi-Sense Guided Coagulation Device with VisiTrax2016-11-07
ATRICURE, INC.
Numeris Guided Coagulation System with Visitrax2016-11-07
ATRICURE, INC.
Numeris Coagulation System with Visitrax (Gen 3 with Tether)2016-11-07
ATRICURE, INC.
Cannula with Balloon Elevator2016-11-07
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2016-10-05
ATRICURE, INC.
AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, PRO22016-03-25
ATRICURE, INC.
AtriClip PROV LAA Exclusion System2016-03-25
AtriCure - Minneapolis [ATRICURE, INC.]
AtriCure cryoICE cryoFORM cryoablation probe (CRYOF)2016-03-25
ATRICURE, INC.
AtriCure cryoICE cryoFORM cryoablation probe (CRYOF)2016-03-25
ATRICURE, INC
CryoFORM CryoICE Cryoablation Probe2016-03-22
ATRICURE, INC.
AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip2016-03-18
Atricure, Inc.
AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove PRO V Clip2016-01-27
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2015-08-26
ATRICURE, INC.
AtriCure Cryo Module System2015-08-06
ATRICURE, INC.
AtriCure Multifunctional linear pen2015-08-06
ATRICURE, INC.
AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip2015-06-17
AtriCure - Minneapolis [ATRICURE, INC.]
CRYO3 - AtriCure cryoICE cryo-ablation probe2015-04-03
ATRICURE, INC.
CRYO3 - AtriCure cryoICE cryo-ablation probe2015-04-03
ATRICURE, INC.
ACH2 - AtriClip LAA Exclusion System2015-04-03
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2015-02-12
ATRICURE, INC.
COBRA Fusion Pacing Recorder Adapter Cable2015-01-02
ATRICURE, INC.
COBRA Fusion Magnetic Retriever2015-01-02
ATRICURE, INC.
COBRA Fusion Magnetic Retriever System Kit2015-01-02
ATRICURE, INC.
COBRA Fusion 50 Ablation System2015-01-02
ATRICURE, INC.
COBRA Fusion 50 Ablation System Kit2015-01-02
ATRICURE, INC.
COBRA Fusion 150 Ablation System2015-01-02
ATRICURE, INC.
COBRA Fusion 150 Ablation System Kit2015-01-02
ATRICURE, INC.
Cobra ElectroSurgical Unit2015-01-02
ATRICURE, INC.
Cobra Cable2015-01-02
ATRICURE, INC.
Cobra ElectroSurgical Unit2015-01-02
ATRICURE, INC.
Cobra Cable2015-01-02
ATRICURE, INC.
COBRA Cooled Surgical Probe2015-01-02
ATRICURE, INC.
COBRA Cooled Surgical Probe with IC2015-01-02
ATRICURE, INC.
COBRA Adhere Surgical System2015-01-02
ATRICURE, INC.
COBRA Cooled Surgical Probe2015-01-02
ATRICURE, INC.
COBRA Cooled Surgical Probe with IC2015-01-02
ATRICURE, INC.
COBRA Adhere Surgical System2015-01-02
ATRICURE, INC.
Window Access SI Retractor Body2015-01-02
ATRICURE, INC.
Window Access SI Retractor Body, Robotic2015-01-02
ATRICURE, INC.
Table Mount Instrument Holders2015-01-02
ATRICURE, INC.
Soft Tissue Atraumatic Retractors (STARs)2015-01-02
ATRICURE, INC.
SI Retractor Blades2015-01-02
ATRICURE, INC.
SI Retractor Blades, Robotic2015-01-02
ATRICURE, INC.
LiV Instruments2015-01-02
ATRICURE, INC.
Hex Posts2015-01-02
ATRICURE, INC.
Hercules Stabilizer Arm2015-01-02
ATRICURE, INC.
Blade Introduction Forceps2015-01-02
ATRICURE, INC.
Atrial Rakes2015-01-02
ATRICURE, INC.
Atrial Lift System2015-01-02
ATRICURE, INC.
Atrial Lift Blades2015-01-02
ATRICURE, INC.
Atrial Lift Blade Holders2015-01-02
ATRICURE, INC.
Aortic Valve Assistants2015-01-02
ATRICURE, INC.
Atricure Cryo Module System; CryoICE Cryoablation Probe2014-11-25
ATRICURE, INC.
CryoICE Croablation Probe2014-10-29
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2014-10-22
ATRICURE, INC.
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP2014-08-28
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2014-06-13
ATRICURE, INC.
ATRICURE CRYO MODULE SYSTEM2014-01-24
ATRICURE, INC.
AtriClip Gillinov-Cosgrove LAA Clip2013-07-12
ATRICURE, INC.
Reusable Clip Applier2013-07-12
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB2013-06-14
ATRICURE, INC.
ATRICLIP GILLINOV-COSGROVE LAA CLIP2013-05-14
ATRICURE, INC.
ISOLATOR LINEAR PEN2013-04-05
ATRICURE, INC.
AtriCure Coolrail linear pen2012-10-22
ATRICURE, INC.
AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, PRO2012-10-22
ATRICURE, INC.
COOLRAIL LINEAR PEN MODEL MCRI2012-09-26
ATRICURE, INC.
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP2012-08-29
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2012-08-15
ATRICURE, INC.
Synergy? Ablation System2012-08-03
ATRICURE, INC.
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)2012-06-06
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2011-12-14
ATRICURE, INC.
ATRICURE CRYO MODULE SYSTEM2011-08-03
ATRICURE, INC.
CryoICE cryo-ablation probe2011-06-23
ATRICURE, INC.
AtriCure Cryo Module2011-06-23
ATRICURE, INC.
AtriCure Cryo Module System2011-06-23
ATRICURE, INC.
Lumitip Dissector2011-06-23
ATRICURE, INC.
Lumitip Dissector2011-06-23
ATRICURE, INC.
ATRICURE DISSECTOR2011-06-09
ATRICURE, INC.
ATRICURE CRYO MODULE2011-05-26
ATRICURE, INC.
Isolator Synergy Access2011-04-18
ATRICURE, INC.
AtriCure Bipolar System2011-04-18
ATRICURE, INC.
ATRICURE BIPOLAR SYSTEM2011-04-08
ATRICURE, INC.
Isolator Synergy Dual Electrode Clamps2010-12-06
ATRICURE, INC.
AtriCure Bipolar System2010-12-06
ATRICURE, INC.
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML22010-11-12
ATRICURE, INC.
Gillinov-Cosgrove Clip2010-06-25
ATRICURE, INC.
AtriClip LAA Exclusion System2010-06-25
ATRICURE, INC.
MULTIFUNCTIONAL LINEAR PEN2010-06-18
ATRICURE, INC.
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA02010-06-10
ATRICURE, INC.
ATRICURE CRYO1 CRYO-ABLATION PROBE2009-03-02
ATRICURE, INC.
AtriCure Bipolar System2008-03-11
ATRICURE, INC.
Isolator pen2008-03-11
ATRICURE, INC.
ACC2 AtriCure Cryosurgical Console2008-03-10
ATRICURE, INC.
Compart Cart2008-03-10
ATRICURE, INC.
ASCS - AtriCure System Cart - Simple2008-03-10
ATRICURE, INC.
ASCF - AtriCure System Cart - Fusion2008-03-10
ATRICURE, INC.
ASCB2 - AtriCure System Cart - Basic2008-03-10
ATRICURE, INC.
ATRICURE BIPOLAR SYSTEM2007-07-05
ATRICURE, INC.
ATRICURE ABLATION SYSTEM2007-01-26
ATRICURE, INC.
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB12006-07-12
ATRICURE, INC.
ATRICURE TRANSPOLAR SYSTEM2005-10-25
ATRICURE, INC.
ATRICURE ISOLATOR TRANSPOLAR PEN2005-06-13
ATRICURE, INC.
Gillinov-Cosgrove Selection Guide2004-08-17
ATRICURE, INC.
Atricure Glidepath Tape2004-08-17
ATRICURE, INC.
ATRICURE DISSECTOR2004-07-01
ATRICURE, INC.
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP12002-04-19
ATRICURE, INC.
ATRICURE BIPOLAR COAGULATION SYSTEM2001-08-30

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