PMA P040043S012

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S012
Product code
MIH
Decision date
2007-01-05
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
CHANGE IN THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE.

Current openFDA PMA Record#

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S012
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2007-01-05
Decision code
OK30
Date received
2006-12-06
Supplement type
30-Day Notice
Approval order statement
CHANGE IN THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE.