PMA P150019S060

Device: Paradigm Real-Tme Revel System
Applicant: Medtronic Minimed
PMA number: P150019
Supplement: S060
Product code: MDS
Decision date: 2019-11-15
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Supplier of the Glucose Oxidase used in the fabrication of the Enlite Sensor and Guardian Sensor (3) moved their manufacturing facility from one location to another within the United Kingdom.

Current openFDA PMA Record#

Device: Paradigm Real-Tme Revel System
Applicant: Medtronic Minimed
PMA number: P150019
Supplement: S060
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2019-11-15
Decision code: OK30
Date received: 2019-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Supplier of the Glucose Oxidase used in the fabrication of the Enlite Sensor and Guardian Sensor (3) moved their manufacturing facility from one location to another within the United Kingdom.