PMA P890055S063

Device: Medstream Programmable Infusion System
Applicant: Intera Oncology
PMA number: P890055
Supplement: S063
Product code: LKK
Decision date: 2016-08-18
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Move downstream manufacturing processes from the Medos International facility located at Chemin Blanc, Le Locle, Switzerland to Codman Neuro Sciences located at Rue Girardet, Le Locle, Switzerland.

Current openFDA PMA Record#

Device: Medstream Programmable Infusion System
Applicant: Intera Oncology
PMA number: P890055
Supplement: S063
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2016-08-18
Decision code: OK30
Date received: 2016-07-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move downstream manufacturing processes from the Medos International facility located at Chemin Blanc, Le Locle, Switzerland to Codman Neuro Sciences located at Rue Girardet, Le Locle, Switzerland.