Product Code: MIH


Products Classified as MIH

1029System, Endovascular Graft, Aortic Aneurysm Treatment

Total Product Life Cycle (TPLC) Devices

1029System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Consensus Standards

System, Endovascular Graft, Aortic Aneurysm Treatment [30301]21 CFR Unclassified 🔎
System, Endovascular Graft, Aortic Aneurysm Treatment [33194]21 CFR Unclassified 🔎
System, Endovascular Graft, Aortic Aneurysm Treatment [38690]21 CFR Unclassified 🔎
System, Endovascular Graft, Aortic Aneurysm Treatment [38470]21 CFR Unclassified 🔎
System, Endovascular Graft, Aortic Aneurysm Treatment [38909]21 CFR Unclassified 🔎
System, Endovascular Graft, Aortic Aneurysm Treatment [38169]21 CFR Unclassified 🔎

Pre-market Approvals for MIH

P110032AORFIX FLEXIBLE STENT GRAFT SYSTEMLombard Medical Limited
P070016ZENITH TX2 TAA ENDVASCULAR GRAFTWILLIAM COOK EUROPE APS
P070027TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEMMedtronic Vascular
P180001Zenith Dissection Endovascular SystemWILLIAM COOK EUROPE APS
P100040Valiant Thoracic Stent Graft with the Captivia Delivery SystemMedtronic Vascular
P040002AFX Endovascular AAA SystemENDOLOGIX, INC.
P020018Zenith AAA Endovascular GraftCOOK, INC.
P020004EXCLUDER AAA EndoprosthesisW.L. GORE & ASSOCIATES,INC
P040043GORE TAG Thoracic EndoprosthesisW. L. GORE & ASSOCIATES, INC.
P100021Endurant, Endurant II, Endurant IIs Stent Graft SystemsMedtronic Vascular
P150002INCRAFT AAA Stent Graft SystemCordis Corporation
P110038Relay Thoracic Stent-Graft with Plus Delivery SystemBOLTON MEDICAL, INC.
P120006Ovation iX Abdominal Stent Graft SystemTRIVASCULAR INC

Global Unique Device Identification Database

00613994802927SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802910SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802903SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802897SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802880SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802873SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802866SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802859SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802842SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802835SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802828SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802811SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802804SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802798SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
00613994802781SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Maude Adverse Events

AFXVELA SUPRARENALENDOLOGIX2020-03-31
AFXBIFURCATED STENT GRAFTENDOLOGIX2020-03-31
OVATION IXENDOLOGIX SANTA ROSA2020-03-31
OVATION IXENDOLOGIX SANTA ROSA2020-03-31
AFX2ENDOLOGIX2020-03-31
OVATION IXENDOLOGIX SANTA ROSA2020-03-31
AFXBIFURCATED STENT GRAFTENDOLOGIX2020-03-31
INTUITRAKENDOLOGIX2020-03-31
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)W.L. GORE & ASSOCIATES2020-03-31
AFXBIFURCATED STENT GRAFTENDOLOGIX2020-03-31
VALIANT CAPTIVIA - CWMEDTRONIC IRELAND2020-03-31
ENDURANT II BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-31
OVATION IXENDOLOGIX SANTA ROSA2020-03-30
AFX2ENDOLOGIX2020-03-30
AFX2ENDOLOGIX2020-03-30
OVATION IXENDOLOGIX SANTA ROSA2020-03-30
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)W.L. GORE & ASSOCIATES2020-03-30
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)W.L. GORE & ASSOCIATES2020-03-30
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEGCOOK INC2020-03-30
AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)W.L. GORE & ASSOCIATES2020-03-30
VALIANT CAPTIVIA - FFMEDTRONIC IRELAND2020-03-30
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)W.L. GORE & ASSOCIATES2020-03-30
ENDURANT II ILIAC STENT GRAFTMEDTRONIC IRELAND2020-03-30
ENDURANT II BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-30
ENDURANT II BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-30
ENDURANT II BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-30
ENDURANT II BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-30
AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)W.L. GORE & ASSOCIATES2020-03-30
AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)W.L. GORE & ASSOCIATES2020-03-27
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)W.L. GORE & ASSOCIATES2020-03-27
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)W.L. GORE & ASSOCIATES2020-03-27
ENDURANT STENT GRAFTMEDTRONIC IRELAND2020-03-27
ENDURANT II EXTENSION CUFFMEDTRONIC IRELAND2020-03-27
ENDURANT IIS BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-27
ENDURANT STENT GRAFTMEDTRONIC IRELAND2020-03-27
ENDURANT IIS BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-27
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)W.L. GORE & ASSOCIATES2020-03-27
AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)W.L. GORE & ASSOCIATES2020-03-26
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)W.L. GORE & ASSOCIATES2020-03-26
AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)W.L. GORE & ASSOCIATES2020-03-26
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)W.L. GORE & ASSOCIATES2020-03-26
ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSIONCOOK INC2020-03-26
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODYCOOK INC2020-03-26
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)W.L. GORE & ASSOCIATES2020-03-26
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)W.L. GORE & ASSOCIATES2020-03-26
ZENITH ALPHA? THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTSWILLIAM COOK EUROPE2020-03-26
ENDURANT II BIFURCATED STENT GRAFTMEDTRONIC IRELAND2020-03-26
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGCOOK INC2020-03-25
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBOLTON MEDICAL, INC.2020-03-25
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODYCOOK INC2020-03-25
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