PMA P890055S006

Device: ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S006
Product code: LKK
Decision date: 1998-09-15
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for the addition of Lioresal Intrathecal (baclofen injection) to the list of drugs approved for use with the M-3000 Implantable Drug Delivery Pump With Bolus Safety Valve.

Current openFDA PMA Record#

Device: ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant: Intera Oncology
PMA number: P890055
Supplement: S006
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1998-09-15
Decision code: APPR
Date received: 1997-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of Lioresal Intrathecal (baclofen injection) to the list of drugs approved for use with the M-3000 Implantable Drug Delivery Pump With Bolus Safety Valve.