Intera 3000 Hepatic Artery Infusion Pump
FDA premarket approval P890055/S089 · decided 2025-05-09
Approval details
- PMA number
- P890055
- Supplement
- S089
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Intera 3000 Hepatic Artery Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2025-04-10
- Decision date
- 2025-05-09
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- labeling change to strengthen warnings about not letting the pump run dry
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