PMA P890055S047

Device
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Applicant
Intera Oncology
PMA number
P890055
Supplement
S047
Product code
LKK
Decision date
2013-01-16
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
APPROVAL FOR A CHANGE TO THE EPIDURAL FILTER COMPONENT OF THE MEDSTREAM REFILL AND BOLUS KIT, OPERATING ROOM (O.R.) PREP KIT, AND INSTRASPINAL CATHETER KIT.

Current openFDA PMA Record#

Device
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Applicant
Intera Oncology
PMA number
P890055
Supplement
S047
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2013-01-16
Decision code
APPR
Date received
2012-11-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A CHANGE TO THE EPIDURAL FILTER COMPONENT OF THE MEDSTREAM REFILL AND BOLUS KIT, OPERATING ROOM (O.R.) PREP KIT, AND INSTRASPINAL CATHETER KIT.