INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
FDA premarket approval P800036/S015 · decided 1995-09-20
Approval details
- PMA number
- P800036
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1987-09-16
- Decision date
- 1995-09-20
- Days to decision
- 2926 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- APPROVAL FOR CHANGE IN LABELING TO INCLUDE EPIDURAL AND INTRATHECAL ADMINISTRATION OF INFUMORPH 200 & 500 CII (PRESERVATIVE-FREE MORPHINE) IN PATIENTS SUFFERING FROM SEVERE AND PROLONGED PAIN WHO ARE NO LONGER RESPONSIVE TO CONVENTIONAL FORMS OF ANALGESIA
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