PMA P890055S045

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US
Applicant: Intera Oncology
PMA number: P890055
Supplement: S045
Product code: LKK
Decision date: 2012-10-12
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL TO ADD GABLOFEN INTRATHECAL TO THE LIST OF APPROVED DRUGS IN THE INSTRUCTIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION IN THE TREATMENT OF SEVERE SPASTICITY.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US
Applicant: Intera Oncology
PMA number: P890055
Supplement: S045
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2012-10-12
Decision code: APPR
Date received: 2012-09-13
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO ADD GABLOFEN INTRATHECAL TO THE LIST OF APPROVED DRUGS IN THE INSTRUCTIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION IN THE TREATMENT OF SEVERE SPASTICITY.