PMA P890055S026

Device: CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S026
Product code: LKK
Decision date: 2010-12-17
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR MEDSTREAM PROGRAMMABLE INFUSION SYSTEM. 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 (5.0 PH TO 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.

Current openFDA PMA Record#

Device: CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S026
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2010-12-17
Decision code: APPR
Date received: 2007-12-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MEDSTREAM PROGRAMMABLE INFUSION SYSTEM. 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 (5.0 PH TO 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.