PMA P040043S032

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S032
Product code
MIH
Decision date
2009-11-20
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
ADDITIONAL PACKAGING EQUIPMENT.

Current openFDA PMA Record#

Device
GORE TAG THORACIC ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040043
Supplement
S032
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2009-11-20
Decision code
OK30
Date received
2009-10-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL PACKAGING EQUIPMENT.