PMA P040043S076

Device
CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S076
Product code
MIH
Decision date
2015-09-04
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
IMPLEMENTATION OF AN OPTIC MEASURING AND LASER CUTTING MACHINE.

Current openFDA PMA Record#

Device
CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S076
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2015-09-04
Decision code
OK30
Date received
2015-08-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF AN OPTIC MEASURING AND LASER CUTTING MACHINE.