ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS
FDA premarket approval P890055/S011 · decided 1999-10-25
Approval details
- PMA number
- P890055
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1999-10-12
- Decision date
- 1999-10-25
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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.
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