PMA P940019S062

Device
WALLSTENT™ ILIAC RP Endoprosthesis
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S062
Product code
NIO
Decision date
2022-11-28
Generic name
STENT, ILIAC
Approval order statement
New method for water bath sterilization.

Current openFDA PMA Record#

Device
WALLSTENT™ ILIAC RP Endoprosthesis
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S062
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2022-11-28
Decision code
OK30
Date received
2022-11-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New method for water bath sterilization.