PMA P890055S071

Device
Codman 3000 Implantable Infusion Pump
Applicant
Intera Oncology
PMA number
P890055
Supplement
S071
Product code
LKK
Decision date
2018-01-12
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Removal of the streaming potential test for the capillary tubing for the Codman 3000 Constant Flow pump.

Current openFDA PMA Record#

Device
Codman 3000 Implantable Infusion Pump
Applicant
Intera Oncology
PMA number
P890055
Supplement
S071
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2018-01-12
Decision code
OK30
Date received
2017-12-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of the streaming potential test for the capillary tubing for the Codman 3000 Constant Flow pump.