PMA P040043S037

Device: GORE TAG THORACIC ENDOPROSTESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S037
Product code: MIH
Decision date: 2011-02-24
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL TO UPDATE THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE TO INCLUDE SUMMARY INFORMATION ON THE EVALUATION OF THE PHYSICIAN TRAINING PROGRAM FOR THIS DEVICE.

Current openFDA PMA Record#

Device: GORE TAG THORACIC ENDOPROSTESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S037
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2011-02-24
Decision code: APPR
Date received: 2010-09-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE TO INCLUDE SUMMARY INFORMATION ON THE EVALUATION OF THE PHYSICIAN TRAINING PROGRAM FOR THIS DEVICE.