MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S040 · decided 2012-06-25
Approval details
- PMA number
- P890055
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2012-05-14
- Decision date
- 2012-06-25
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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.
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