PMA P040043S010

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S010
Product code: MIH
Decision date: 2006-06-16
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE PROCEDURES EMPLOYED IN THE LABELING OF THE GORE TAG THORACIC ENDOPROSTHESIS. THESE MODIFICATIONS ARE INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE BY MINIMIZING THE POTENTIAL FOR MISLABELING OF DEVICES.

Current openFDA PMA Record#

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S010
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2006-06-16
Decision code: APPR
Date received: 2006-05-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE PROCEDURES EMPLOYED IN THE LABELING OF THE GORE TAG THORACIC ENDOPROSTHESIS. THESE MODIFICATIONS ARE INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE BY MINIMIZING THE POTENTIAL FOR MISLABELING OF DEVICES.