PMA P040043S008

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S008
Product code: MIH
Decision date: 2006-01-20
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE (IFU) TO REINFORCE THE NECESSITY OF ADHERING TO THE SIZING GUIDELINES INCLUDED IN THE IFU.

Current openFDA PMA Record#

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S008
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2006-01-20
Decision code: APPR
Date received: 2005-12-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE (IFU) TO REINFORCE THE NECESSITY OF ADHERING TO THE SIZING GUIDELINES INCLUDED IN THE IFU.