CONSTANT FLOW IMPLANTABLE INFUSION PUMP
FDA premarket approval P890055/S009 · decided 2000-01-21
Approval details
- PMA number
- P890055
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSTANT FLOW IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1999-02-23
- Decision date
- 2000-01-21
- Days to decision
- 332 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for adding the Drug Lioresal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps. Also, the label will clearly indicate that baclofen is stable for 44 days at 37C.
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