PMA P890055S092
- Device
- lntera 3000 Hepatic Artery Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S092
- Product code
- LKK
- Decision date
- 2026-02-26
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for updates to the labeling and instructions for use.
Current openFDA PMA Record#
- Device
- lntera 3000 Hepatic Artery Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S092
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2026-02-26
- Decision code
- APPR
- Date received
- 2025-11-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the labeling and instructions for use.