PMA P980033S014

Device
WALLSTENT VENOUS ENDOPROSTHESIS
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S014
Product code
QKJ
Decision date
2006-06-08
Classification
Stent, Coronary
Generic name
Stent, central venous
Approval order statement
ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).

Current openFDA PMA Record#

Device
WALLSTENT VENOUS ENDOPROSTHESIS
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S014
Product code
QKJ
Generic name
Stent, central venous
Decision date
2006-06-08
Decision code
OK30
Date received
2006-05-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).