PMA P940019S044

Device
WALLSTENT ILIAC ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S044
Product code
NIO
Decision date
2014-05-23
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.

Current openFDA PMA Record#

Device
WALLSTENT ILIAC ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S044
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2014-05-23
Decision code
OK30
Date received
2014-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.