PMA P980033S045

Device
WALLSTENT ENDOPROSTHESIS (VENOUS)
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S045
Product code
QKJ
Decision date
2016-08-24
Classification
Stent, Coronary
Generic name
Stent, central venous
Approval order statement
Outsourcing the compounding process for numerous resins.

Current openFDA PMA Record#

Device
WALLSTENT ENDOPROSTHESIS (VENOUS)
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S045
Product code
QKJ
Generic name
Stent, central venous
Decision date
2016-08-24
Decision code
OK30
Date received
2016-07-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Outsourcing the compounding process for numerous resins.