PMA P090003S050

Device
Express LD Iliac Premounted Stent System
Applicant
Boston Scientific Corporation
PMA number
P090003
Supplement
S050
Product code
NIO
Decision date
2020-11-18
Generic name
STENT, ILIAC
Approval order statement
Change to equipment used for the stent laser cutting process.

Current openFDA PMA Record#

Device
Express LD Iliac Premounted Stent System
Applicant
Boston Scientific Corporation
PMA number
P090003
Supplement
S050
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2020-11-18
Decision code
OK30
Date received
2020-10-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to equipment used for the stent laser cutting process.