FDA.reportPublic FDA data

PMA P890055S066

Device
INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant
Intera Oncology
PMA number
P890055
Supplement
S066
Product code
LKK
Decision date
2017-02-21
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Changing the manufacturing of blister lids from Smith Print to Mangar Medical Packaging. This change applies to the: Codman Pump Catheter (602914US) and SureStream Intraspinal Catheter kit (70020US).

Current openFDA PMA Record#

Device
INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant
Intera Oncology
PMA number
P890055
Supplement
S066
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2017-02-21
Decision code
OK30
Date received
2017-02-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changing the manufacturing of blister lids from Smith Print to Mangar Medical Packaging. This change applies to the: Codman Pump Catheter (602914US) and SureStream Intraspinal Catheter kit (70020US).