PMA P890055S090

Device: Intera 3000 Hepatic Arterial Infusion Pump
Applicant: Intera Oncology
PMA number: P890055
Supplement: S090
Product code: LKK
Decision date: 2025-05-07
Classification: General Hospital
Generic name: Pump, infusion, implanted, programmable
Approval order statement: The addition of an inspection process for the Capillary Assembly, the addition of two tools that guide the insertion depth of the Capillary Assembly, and the change of material for the pointer tool used in the manufacturing process.

Current openFDA PMA Record#

Device: Intera 3000 Hepatic Arterial Infusion Pump
Applicant: Intera Oncology
PMA number: P890055
Supplement: S090
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2025-05-07
Decision code: OK30
Date received: 2025-04-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The addition of an inspection process for the Capillary Assembly, the addition of two tools that guide the insertion depth of the Capillary Assembly, and the change of material for the pointer tool used in the manufacturing process.