M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
FDA premarket approval P890055/S001 · decided 1996-06-27
Approval details
- PMA number
- P890055
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1996-06-05
- Decision date
- 1996-06-27
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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
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