PMA P890055S035

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S035
Product code: LKK
Decision date: 2012-01-05
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE PASSIVATION OF COMPONENTS NEEDED TO MANUFACTURE ACCESSORIES USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S035
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2012-01-05
Decision code: APPR
Date received: 2011-09-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE PASSIVATION OF COMPONENTS NEEDED TO MANUFACTURE ACCESSORIES USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.