PMA P980033S033

Device
WALLSTENT (VENOUS) ENDOPROSTHESIS UNISTEP PLUS DELIVERY SYSTEM
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S033
Product code
QKJ
Decision date
2013-06-26
Classification
Stent, Coronary
Generic name
Stent, central venous
Approval order statement
CHANGE TO THE BRAIDING INSPECTION PROCESS.

Current openFDA PMA Record#

Device
WALLSTENT (VENOUS) ENDOPROSTHESIS UNISTEP PLUS DELIVERY SYSTEM
Applicant
Boston Scientific Corporation
PMA number
P980033
Supplement
S033
Product code
QKJ
Generic name
Stent, central venous
Decision date
2013-06-26
Decision code
OK30
Date received
2013-05-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE BRAIDING INSPECTION PROCESS.