PMA P040043S007

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S007
Product code
MIH
Decision date
2005-11-30
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
ELIMINATION OF A REDUNDANT STENT WIRE CLEANING STEP.

Current openFDA PMA Record#

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S007
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2005-11-30
Decision code
OK30
Date received
2005-11-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ELIMINATION OF A REDUNDANT STENT WIRE CLEANING STEP.