PMA P890055S039

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S039
Product code: LKK
Decision date: 2012-04-30
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR CONTROL UNIT CIRCUITRY HARDWARE MODIFICATIONS WHICH INCLUDED POTENTIOMETER VALUE CHANGE, RESISTANCE VALUE CHANGE AND CAPACITOR TOLERANCE NARROWING.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S039
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2012-04-30
Decision code: APPR
Date received: 2012-03-16
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CONTROL UNIT CIRCUITRY HARDWARE MODIFICATIONS WHICH INCLUDED POTENTIOMETER VALUE CHANGE, RESISTANCE VALUE CHANGE AND CAPACITOR TOLERANCE NARROWING.