INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
FDA premarket approval P800036/S013 · decided 1988-11-04
Approval details
- PMA number
- P800036
- Supplement
- S013
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1985-12-10
- Decision date
- 1988-11-04
- Days to decision
- 1060 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
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