FDA.report

Product code MIH

Current FDA Classification

Device name
System, Endovascular Graft, Aortic Aneurysm Treatment
Medical specialty
Unknown
Device class
3
Review panel
CV
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible

Related PMA Records

PMADeviceApplicantDecision date
P040043S113GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL SystemW. L. GORE & ASSOCIATES, INC.2019-10-31
P180001S001Zenith Dissection Endovascular SystemWILLIAM COOK EUROPE APS2019-10-31
P110038S024Relay Thoracic Stent-Graft with Plus Delivery SystemBOLTON MEDICAL, INC.2019-10-30
P020004S171GORE EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-10-24
P100021S078Talent Occluder with Occluder Delivery SystemMedtronic Vascular2019-10-17
P100040S039Valiant Thoracic Stent Graft With the Captivia Delivery SystemMedtronic Vascular2019-10-17
P020004S170GORE EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-10-08
P040043S110GORE TAG Thoracic EndoprosthesisW. L. GORE & ASSOCIATES, INC.2019-10-02
P020004S164GORE EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-10-02
P020004S168EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-09-26
P040002S063AFX Endovascular AAA SystemENDOLOGIX, INC.2019-08-16
P150002S006INCRAFT(R) AAA Stent Graft SystemCordis Corporation2019-08-15
P150002S005Cordis Incraft AAA Stent Graft SystemCordis Corporation2019-07-10
P150002S004INCRAFT(R) AAA Stent Graft SystemCordis Corporation2019-06-21
P150002S003Incraft (R) AAA Stent Graft SystemCordis Corporation2019-06-21
P150002S002Incraft AAA Stent Graft SystemCordis Corporation2019-05-30
P040043S106GORE TAG Thoracic Stent Graft with ACTIVE CONTROL SystemW. L. GORE & ASSOCIATES, INC.2019-05-14
P040043S111Gore Tag Thoracic EndoprosthesisW. L. GORE & ASSOCIATES, INC.2019-05-13
P020004S165Gore Excluder AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-05-13
P100040S038Valiant Thoracic Stent Graft with the Captivia Delivery SystemMedtronic Vascular2019-05-05
P100021S076Endurant, Endurant II and Endurant IIs Stent Graft SystemMedtronic Vascular2019-05-05
P120006S032Ovation iX Abdominal Stent Graft SystemTRIVASCULAR INC2019-04-24
P110038S023Relay Thoracic Stent-Graft with Plus Delivery SystemBOLTON MEDICAL, INC.2019-04-19
P150002S001INCRAFT AAA Stent Graft SystemCordis Corporation2019-03-26
P040043S109GORE TAG Thoracic EndoprosthesisW. L. GORE & ASSOCIATES, INC.2019-03-18
P020004S163GORE EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-03-18
P100021S072Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, EndurMedtronic Vascular2019-03-08
P100021S075Endurant, Endurant II, Endurant IIs Stent Graft SystemsMedtronic Vascular2019-02-21
P040043S108GORE TAG Thoracic EndoprosthesisW. L. GORE & ASSOCIATES, INC.2019-01-02
P020004S162EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC2019-01-02

Related GUDID Devices

Primary DIBrandCompanyPublished
10827002603414COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603421COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603438COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603445COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603452COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
10827002603407COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.2025-06-24
00733132661688GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.2025-03-18
00733132661695GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.2025-03-18
00733132661671GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.2025-03-18
00733132661664GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.2025-03-18
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10827002602127Zenith AlphaWilliam Cook Europe ApS2024-12-18
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10827002602073Zenith AlphaWilliam Cook Europe ApS2024-12-18
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10827002601984Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601953Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601922Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601892Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601861Zenith AlphaWilliam Cook Europe ApS2024-12-18
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10827002601748Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601717Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601656Zenith AlphaWilliam Cook Europe ApS2024-12-18
10827002601595Zenith AlphaWilliam Cook Europe ApS2024-12-18