- Device
- Intera 3000 Hepatic Artery Infusion Pump accessories
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S077
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-04-13
- Decision code
- OK30
- Date received
- 2021-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the firms responsible for receiving and inspection activities for the barbed connector and tapered catheter components, cleaning and passivating of the barbed connector component, and packaging, sealing, and labeling of the barbed connector and tapered catheter components for the Intera 3000 Hepatic Artery Infusion Pump.