IMPLANTABLE INFUSION PUMPS
FDA premarket approval P890055/S015 · decided 2002-09-24
Approval details
- PMA number
- P890055
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMPLANTABLE INFUSION PUMPS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2002-06-21
- Decision date
- 2002-09-24
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR A CHANGE TO THE LABELING TO ADD A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY STATEMENT. ONE LABEL IS A MRI DATA CHART AND ONE LABEL IS A TECHNICAL REPORT DESCRIBING THE EFFECTS OF MRI ON THE DEVICE.
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