PMA P040037S026

Device
GORE VIABAHN ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040037
Supplement
S026
Product code
NIP
Decision date
2010-06-23
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
ALTERNATE METHOD FOR APPLYING HEPARIN COATING.

Current openFDA PMA Record#

Device
GORE VIABAHN ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040037
Supplement
S026
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2010-06-23
Decision code
OK30
Date received
2010-05-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE METHOD FOR APPLYING HEPARIN COATING.