PMA P890055S002

Device: MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S002
Product code: LKK
Decision date: 1997-02-04
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR (1) A CHANGE IN LABELING FOR THE MDOEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE TO INCLUDE AN INDICATION FOR THE INTRASPINAL DELVIERY OF PRESERVATIVE-FREE MORPHINE SULFATE FOR THE TREATMENT OF PAIN OF MALIGNANT ORIGIN AND (2) THE INTRASPINAL CATHETER KIT.

Current openFDA PMA Record#

Device: MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S002
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1997-02-04
Decision code: APPR
Date received: 1996-06-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR (1) A CHANGE IN LABELING FOR THE MDOEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE TO INCLUDE AN INDICATION FOR THE INTRASPINAL DELVIERY OF PRESERVATIVE-FREE MORPHINE SULFATE FOR THE TREATMENT OF PAIN OF MALIGNANT ORIGIN AND (2) THE INTRASPINAL CATHETER KIT.