PMA P800036S039

Device: Model 400 Implantable Infusion Pump
Applicant: Intera Oncology
PMA number: P800036
Supplement: S039
Product code: LKK
Decision date: 2016-08-29
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.

Current openFDA PMA Record#

Device: Model 400 Implantable Infusion Pump
Applicant: Intera Oncology
PMA number: P800036
Supplement: S039
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2016-08-29
Decision code: OK30
Date received: 2016-08-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.