PMA P890055S043
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S043
- Product code
- LKK
- Decision date
- 2012-10-16
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order 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.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S043
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2012-10-16
- Decision code
- APPR
- Date received
- 2012-08-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.