PMA P980033S041

Device
WALLSTENT VENOUS ENDOPROSTHESIS
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S041
Product code
QKJ
Decision date
2014-05-23
Classification
Stent, Coronary
Generic name
Stent, central venous
Approval order statement
RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.

Current openFDA PMA Record#

Device
WALLSTENT VENOUS ENDOPROSTHESIS
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S041
Product code
QKJ
Generic name
Stent, central venous
Decision date
2014-05-23
Decision code
OK30
Date received
2014-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.