INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400
FDA premarket approval P800036/S030 · decided 1995-08-14
Approval details
- PMA number
- P800036
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1993-12-29
- Decision date
- 1995-08-14
- Days to decision
- 593 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- APPROVAL FOR LABELING CHANGE
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