PMA P890055S013

Device: MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
Applicant: Intera Oncology
PMA number: P890055
Supplement: S013
Product code: LKK
Decision date: 2002-10-18
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR THE INDICATIONS FOR USE TO INCLUDE GLYCERIN INJECTION AS AN INFUSATE FOR USE WITH PATIENTS WHO ARE RECEIVING CONTINUOUS HEPATIC ARTERIAL FUDR CHEMOTHERAPY WITH THE ARROW INTERNATIONAL MODEL 3000 SERIES OF IMPLANTABLE INFUSION PUMPS TO KEEP THE CATHETER PATENT OR TO EXTEND THE REFILL INTERVAL FOR PATIENTS WHO REQUIRE THERAPY OR WITHDRAWAL.

Current openFDA PMA Record#

Device: MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
Applicant: Intera Oncology
PMA number: P890055
Supplement: S013
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2002-10-18
Decision code: APPR
Date received: 2001-06-06
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE INDICATIONS FOR USE TO INCLUDE GLYCERIN INJECTION AS AN INFUSATE FOR USE WITH PATIENTS WHO ARE RECEIVING CONTINUOUS HEPATIC ARTERIAL FUDR CHEMOTHERAPY WITH THE ARROW INTERNATIONAL MODEL 3000 SERIES OF IMPLANTABLE INFUSION PUMPS TO KEEP THE CATHETER PATENT OR TO EXTEND THE REFILL INTERVAL FOR PATIENTS WHO REQUIRE THERAPY OR WITHDRAWAL.