PMA P040043S051
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S051
- Product code
- MIH
- Decision date
- 2013-09-10
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THIS DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA, INCLUDING:1) ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM; AND C) > 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.2) TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) > 20 MM LANDING ZONE PROXIMAL TO THE PRIMARY ENTRY TEAR; PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED; ANDC) DIAMETER AT PROXIMAL EXTENT OF PROXIMAL LANDING ZONE IN THE RANGE OF 16-42 MM.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040043S051B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- GORE TAG THORACIC ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S051
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-09-10
- Decision code
- APPR
- Date received
- 2013-03-14
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THIS DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA, INCLUDING:1) ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM; AND C) > 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.2) TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) > 20 MM LANDING ZONE PROXIMAL TO THE PRIMARY ENTRY TEAR; PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED; ANDC) DIAMETER AT PROXIMAL EXTENT OF PROXIMAL LANDING ZONE IN THE RANGE OF 16-42 MM.