PMA P890055S004

Device: ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S004
Product code: LKK
Decision date: 1998-03-17
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for the Arrow Model 3000-16 Constant Flow Implantable Pump with Bolus Safety Valve for adult use for the following indications: 1)the intraspinal delivery of preservative free morphine for patients with intractable chronic pain, 2)the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.

Current openFDA PMA Record#

Device: ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S004
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1998-03-17
Decision code: APPR
Date received: 1997-06-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Arrow Model 3000-16 Constant Flow Implantable Pump with Bolus Safety Valve for adult use for the following indications: 1)the intraspinal delivery of preservative free morphine for patients with intractable chronic pain, 2)the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.