PMA P890055S011
- Device
- ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S011
- Product code
- LKK
- Decision date
- 1999-10-25
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for the following modifications: 1) Increasing the Flex Tip Plus Intraspinal Catheter length; 2) Combining the infusion pump and the approved refill kit to facilitate the pump pre-implant procedure; 3) Adding a thermometer to the packaging for the monitoring of water bath temperature; and 4) Adding an informational chart of drug solution to the labeling.
Current openFDA PMA Record#
- Device
- ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S011
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 1999-10-25
- Decision code
- APPR
- Date received
- 1999-10-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the following modifications: 1) Increasing the Flex Tip Plus Intraspinal Catheter length; 2) Combining the infusion pump and the approved refill kit to facilitate the pump pre-implant procedure; 3) Adding a thermometer to the packaging for the monitoring of water bath temperature; and 4) Adding an informational chart of drug solution to the labeling.