PMA P980033S046

Device
WALLSTENT ENDOPROSTHESIS VENOUS
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S046
Product code
QKJ
Decision date
2016-10-12
Classification
Stent, Coronary
Generic name
Stent, central venous
Approval order statement
Equipment update to automate features and implementation of a manufacturing database.

Current openFDA PMA Record#

Device
WALLSTENT ENDOPROSTHESIS VENOUS
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S046
Product code
QKJ
Generic name
Stent, central venous
Decision date
2016-10-12
Decision code
OK30
Date received
2016-09-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Equipment update to automate features and implementation of a manufacturing database.