MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S043 · decided 2012-10-16
Approval details
- PMA number
- P890055
- Supplement
- S043
- 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
- 2012-08-14
- Decision date
- 2012-10-16
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR A MODIFICATION TO THE PROGRAMMABLE INFUSION SYSTEM. THIS MODIFICATION CONSISTED OF REMOVAL OF THE EPOXY USED ON THE WIRES OF THE ACTUATOR COMPONENT OF THE PUMP.
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