PMA P940019S066

Device
WALLSTENT™ ILIAC RP Endoprosthesis
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S066
Product code
NIO
Decision date
2024-06-27
Classification
Cardiovascular
Generic name
STENT, ILIAC
Approval order statement
a new automated cleaning system at your component supplier

Current openFDA PMA Record#

Device
WALLSTENT™ ILIAC RP Endoprosthesis
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S066
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2024-06-27
Decision code
OK30
Date received
2024-06-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new automated cleaning system at your component supplier