PMA P940019S048

Device
WALLSTENT ENDOPROSTHESIS LLIAC
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S048
Product code
NIO
Decision date
2016-10-12
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
Equipment update to automate features and implementation of a manufacturing database.

Current openFDA PMA Record#

Device
WALLSTENT ENDOPROSTHESIS LLIAC
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S048
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2016-10-12
Decision code
OK30
Date received
2016-09-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Equipment update to automate features and implementation of a manufacturing database.