PMA P980033S004

Device
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S004
Product code
QKJ
Decision date
2003-01-10
Classification
Stent, Coronary
Generic name
Stent, central venous
Approval order statement
CHANGE FROM A MANUAL TO AN AUTOMATIC CLEANING AND PASSIVATION PROCESS.

Current openFDA PMA Record#

Device
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S004
Product code
QKJ
Generic name
Stent, central venous
Decision date
2003-01-10
Decision code
OK30
Date received
2002-12-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE FROM A MANUAL TO AN AUTOMATIC CLEANING AND PASSIVATION PROCESS.