PMA P040043S040

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S040
Product code: MIH
Decision date: 2012-01-13
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ISOLATED LESIONS (NOT INCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA, IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING ADEQUATE ILIAC/FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.

Current openFDA PMA Record#

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S040
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2012-01-13
Decision code: APPR
Date received: 2011-07-01
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ISOLATED LESIONS (NOT INCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA, IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING ADEQUATE ILIAC/FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.