PMA P890055S010
- Device
- ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S010
- Product code
- LKK
- Decision date
- 1999-05-27
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for the following modifications to the device: 1)Replacement of the standard 50 ml syring with a calibrated syringe in the refill kit and related labeling; 2) the incorporation of a special bolus winged infusion set; 3) Increase the volume of water placed into the pump reservoir prior to sterilization; 4) Revise the labeling to refer the user to the instruction for use of the device.
Current openFDA PMA Record#
- Device
- ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S010
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 1999-05-27
- Decision code
- APPR
- Date received
- 1999-05-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the following modifications to the device: 1)Replacement of the standard 50 ml syring with a calibrated syringe in the refill kit and related labeling; 2) the incorporation of a special bolus winged infusion set; 3) Increase the volume of water placed into the pump reservoir prior to sterilization; 4) Revise the labeling to refer the user to the instruction for use of the device.