PMA P890055S048

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S048
Product code: LKK
Decision date: 2014-07-15
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE MEDSTREAM DEVICE TO REQUIRE A POST-STERILIZATION FILL LEVEL SENSOR (FLS) FUNCTIONAL INSPECTION.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S048
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2014-07-15
Decision code: APPR
Date received: 2013-06-28
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE MEDSTREAM DEVICE TO REQUIRE A POST-STERILIZATION FILL LEVEL SENSOR (FLS) FUNCTIONAL INSPECTION.