PMA P040043S019

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S019
Product code: MIH
Decision date: 2009-03-04
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE WITH CLINICAL DATA ON SUBJECTS WITH RUPTURED ANEURYSMS OF THE DESCENDING THORACIC AORTA.

Current openFDA PMA Record#

Device: GORE TAG THORACIC ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S019
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2009-03-04
Decision code: APPR
Date received: 2007-10-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE WITH CLINICAL DATA ON SUBJECTS WITH RUPTURED ANEURYSMS OF THE DESCENDING THORACIC AORTA.