- Device
- M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S001
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 1996-06-27
- Decision code
- APPR
- Date received
- 1996-06-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE "MODEL 3000 MEDICATION CALCULATOR" TO THE LABELING FOR THE M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE