PMA P040043S071

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S071
Product code
MIH
Decision date
2015-01-22
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
IMPLEMENTATION OF MODIFIED THERMAL PROCESSING PARAMETERS FOR THE ULTRA THIN WALL BASETUBE GRAFT COMPONENT.

Current openFDA PMA Record#

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S071
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2015-01-22
Decision code
OK30
Date received
2014-12-22
Supplement type
30-Day Notice
Approval order statement
IMPLEMENTATION OF MODIFIED THERMAL PROCESSING PARAMETERS FOR THE ULTRA THIN WALL BASETUBE GRAFT COMPONENT.