PMA P980033S063

Device
VENOUS WALLSTENT™ Self-Expanding Stent
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S063
Product code
QKJ
Decision date
2023-08-04
Classification
Cardiovascular
Generic name
Stent, central venous
Approval order statement
Supplier addition for the interior tubing for the devices in the submission.

Current openFDA PMA Record#

Device
VENOUS WALLSTENT™ Self-Expanding Stent
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S063
Product code
QKJ
Generic name
Stent, central venous
Decision date
2023-08-04
Decision code
OK30
Date received
2023-07-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Supplier addition for the interior tubing for the devices in the submission.