ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
FDA premarket approval P890055/S004 · decided 1998-03-17
Approval details
- PMA number
- P890055
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1997-06-24
- Decision date
- 1998-03-17
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for the Arrow Model 3000-16 Constant Flow Implantable Pump with Bolus Safety Valve for adult use for the following indications: 1)the intraspinal delivery of preservative free morphine for patients with intractable chronic pain, 2)the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.
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