PMA P890055S049

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S049
Product code: LKK
Decision date: 2013-09-20
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS TO PROVIDE USERS WITH INFORMATION REGARDING STEPS THAT SHOULD BE TAKEN TO PREVENT A POTENTIAL ADVERSE REACTION WHEN FILLING THE PUMP RESERVOIR.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S049
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2013-09-20
Decision code: APPR
Date received: 2013-08-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS TO PROVIDE USERS WITH INFORMATION REGARDING STEPS THAT SHOULD BE TAKEN TO PREVENT A POTENTIAL ADVERSE REACTION WHEN FILLING THE PUMP RESERVOIR.