PMA P890055S038

Device: CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES
Applicant: Intera Oncology
PMA number: P890055
Supplement: S038
Product code: LKK
Decision date: 2012-01-17
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: MANUFACTURING PROCESS CHANGE TO THE DEVICE USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.

Current openFDA PMA Record#

Device: CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES
Applicant: Intera Oncology
PMA number: P890055
Supplement: S038
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2012-01-17
Decision code: OK30
Date received: 2011-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE TO THE DEVICE USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.