ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
FDA premarket approval P890055/S006 · decided 1998-09-15
Approval details
- PMA number
- P890055
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 1997-09-30
- Decision date
- 1998-09-15
- Days to decision
- 350 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for the addition of Lioresal Intrathecal (baclofen injection) to the list of drugs approved for use with the M-3000 Implantable Drug Delivery Pump With Bolus Safety Valve.
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