PMA P040037S054

Device
GORE VIBAHN ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040037
Supplement
S054
Product code
NIP
Decision date
2013-08-05
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
NEW WRAPPER MACHINE.

Current openFDA PMA Record#

Device
GORE VIBAHN ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040037
Supplement
S054
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2013-08-05
Decision code
OK30
Date received
2013-07-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
NEW WRAPPER MACHINE.