PMA P890055S089
- Device
- Intera 3000 Hepatic Artery Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S089
- Product code
- LKK
- Decision date
- 2025-05-09
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- labeling change to strengthen warnings about not letting the pump run dry
Current openFDA PMA Record#
- Device
- Intera 3000 Hepatic Artery Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S089
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-05-09
- Decision code
- APPR
- Date received
- 2025-04-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- labeling change to strengthen warnings about not letting the pump run dry