PMA P090003S051

Device
Express LD Iliac Premounted Stent System
Applicant
Boston Scientific Corporation
PMA number
P090003
Supplement
S051
Product code
NIO
Decision date
2021-04-30
Generic name
STENT, ILIAC
Approval order statement
Approval for the use of an alternate strain relief component of the delivery system Y-connector assembly.

Current openFDA PMA Record#

Device
Express LD Iliac Premounted Stent System
Applicant
Boston Scientific Corporation
PMA number
P090003
Supplement
S051
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2021-04-30
Decision code
APPR
Date received
2021-03-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the use of an alternate strain relief component of the delivery system Y-connector assembly.