PMA P040043S031

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S031
Product code: MIH
Decision date: 2010-03-23
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR ADDING THE 45MM TAG THORACIC ENDOPROSTHESIS TO THE ALREADY EXISTING TAG THORACIC ENDOPROSTHESIS PRODUCT FAMILY. THE TAG DEVICE IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC/ FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 23-42MM, AND >=2CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.

Current openFDA PMA Record#

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S031
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2010-03-23
Decision code: APPR
Date received: 2009-09-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDING THE 45MM TAG THORACIC ENDOPROSTHESIS TO THE ALREADY EXISTING TAG THORACIC ENDOPROSTHESIS PRODUCT FAMILY. THE TAG DEVICE IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC/ FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 23-42MM, AND >=2CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.