PMA P890055S001

Device
M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant
Intera Oncology
PMA number
P890055
Supplement
S001
Product code
LKK
Decision date
1996-06-27
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
APPROVAL FOR THE ADDITION OF THE "MODEL 3000 MEDICATION CALCULATOR" TO THE LABELING FOR THE M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE

Current openFDA PMA Record#

Device
M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Applicant
Intera Oncology
PMA number
P890055
Supplement
S001
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
1996-06-27
Decision code
APPR
Date received
1996-06-05
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE ADDITION OF THE "MODEL 3000 MEDICATION CALCULATOR" TO THE LABELING FOR THE M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE