PMA P940019S051

Device
Wallstent Illiac Endoprosthesis with unistep plus delivery system
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S051
Product code
NIO
Decision date
2017-07-03
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
Alternate vendor for stainless steel tubing for use in the delivery system.

Current openFDA PMA Record#

Device
Wallstent Illiac Endoprosthesis with unistep plus delivery system
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S051
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2017-07-03
Decision code
OK30
Date received
2017-06-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate vendor for stainless steel tubing for use in the delivery system.