PMA P890055S070

Device: MedStream Programmable Infusion Pump Control Unit
Applicant: Intera Oncology
PMA number: P890055
Supplement: S070
Product code: LKK
Decision date: 2017-10-16
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Transfer of the downstream manufacturing processes for the MedStream Control Unit from the Medos Sarl facility to the Medos International facility.

Current openFDA PMA Record#

Device: MedStream Programmable Infusion Pump Control Unit
Applicant: Intera Oncology
PMA number: P890055
Supplement: S070
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2017-10-16
Decision code: OK30
Date received: 2017-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer of the downstream manufacturing processes for the MedStream Control Unit from the Medos Sarl facility to the Medos International facility.