PMA P890055S040
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S040
- Product code
- LKK
- Decision date
- 2012-06-25
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR SOFTWARE MODIFICATIONS TO THE PROGRAMMABLE INFUSION SYSTEM. THESE MODIFICATIONS WERE DATA INTEGRITY CHECK IMPROVEMENT, RESOLUTION OF CONTROL UNIT KEYBOARD, FRAME CHECK SEQUENCE ALGORITHM UPGRADE, SOFTWARE ANOMALIES 015, 016, 017, 020 FIX, AND IMPROVEMENT OF THE BRIDGE BOLUS, PRIMING BOLUS AND SINGLE BOLUS PROCESSES.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S040
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2012-06-25
- Decision code
- APPR
- Date received
- 2012-05-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE MODIFICATIONS TO THE PROGRAMMABLE INFUSION SYSTEM. THESE MODIFICATIONS WERE DATA INTEGRITY CHECK IMPROVEMENT, RESOLUTION OF CONTROL UNIT KEYBOARD, FRAME CHECK SEQUENCE ALGORITHM UPGRADE, SOFTWARE ANOMALIES 015, 016, 017, 020 FIX, AND IMPROVEMENT OF THE BRIDGE BOLUS, PRIMING BOLUS AND SINGLE BOLUS PROCESSES.