INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400
FDA premarket approval P800036/S029 · decided 1993-06-17
Approval details
- PMA number
- P800036
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1992-05-18
- Decision date
- 1993-06-17
- Days to decision
- 395 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
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