PMA P890055S081
- Device
- Intera 3000 Hepatic Artery Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S081
- Product code
- LKK
- Decision date
- 2022-06-22
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for changes to Instructions for Use.
Current openFDA PMA Record#
- Device
- Intera 3000 Hepatic Artery Infusion Pump
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S081
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2022-06-22
- Decision code
- APPR
- Date received
- 2022-05-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to Instructions for Use.