PMA P940019S047

Device
WALLSTENT ILIAC ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S047
Product code
NIO
Decision date
2016-08-24
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
Outsourcing the compounding process for numerous resins.

Current openFDA PMA Record#

Device
WALLSTENT ILIAC ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S047
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2016-08-24
Decision code
OK30
Date received
2016-07-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Outsourcing the compounding process for numerous resins.