PMA P890055S015

Device: IMPLANTABLE INFUSION PUMPS
Applicant: Intera Oncology
PMA number: P890055
Supplement: S015
Product code: LKK
Decision date: 2002-09-24
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR A CHANGE TO THE LABELING TO ADD A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY STATEMENT. ONE LABEL IS A MRI DATA CHART AND ONE LABEL IS A TECHNICAL REPORT DESCRIBING THE EFFECTS OF MRI ON THE DEVICE.

Current openFDA PMA Record#

Device: IMPLANTABLE INFUSION PUMPS
Applicant: Intera Oncology
PMA number: P890055
Supplement: S015
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2002-09-24
Decision code: APPR
Date received: 2002-06-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE TO THE LABELING TO ADD A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY STATEMENT. ONE LABEL IS A MRI DATA CHART AND ONE LABEL IS A TECHNICAL REPORT DESCRIBING THE EFFECTS OF MRI ON THE DEVICE.