PMA P980033S059

Device
Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S059
Product code
QKJ
Decision date
2022-06-28
Generic name
Stent, central venous
Approval order statement
Addition of a delivery system distal tip supplier.

Current openFDA PMA Record#

Device
Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S059
Product code
QKJ
Generic name
Stent, central venous
Decision date
2022-06-28
Decision code
OK30
Date received
2022-06-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a delivery system distal tip supplier.