FDA.reportPublic FDA data

PMA P890055S064

Device
Codman 3000 Series Constant-Flow Implantable Infusion Pump and MedStream Implantable Infusion Pump
Applicant
Intera Oncology
PMA number
P890055
Supplement
S064
Product code
LKK
Decision date
2016-08-29
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.

Current openFDA PMA Record#

Device
Codman 3000 Series Constant-Flow Implantable Infusion Pump and MedStream Implantable Infusion Pump
Applicant
Intera Oncology
PMA number
P890055
Supplement
S064
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2016-08-29
Decision code
OK30
Date received
2016-08-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.