PMA P890055S007

Device: ARROW INTERNATIONAL MODEL 3000-50 ML CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S007
Product code: LKK
Decision date: 1999-01-11
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for the Arrow Model 3000-50 Constant Flow Implantable Pump for adults for the following indications: 1)the intraspinal delivery of preservative free morphine for patient with intractable chronic pain, 2) the intraspinal deliery of preservative free morphine for the treatment of pain ofmalignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.

Current openFDA PMA Record#

Device: ARROW INTERNATIONAL MODEL 3000-50 ML CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S007
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1999-01-11
Decision code: APPR
Date received: 1998-05-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Arrow Model 3000-50 Constant Flow Implantable Pump for adults for the following indications: 1)the intraspinal delivery of preservative free morphine for patient with intractable chronic pain, 2) the intraspinal deliery of preservative free morphine for the treatment of pain ofmalignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.