|
Device | Paradigm Real-Tme Revel System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S060 |
Date Received | 10/17/2019 |
Decision Date | 11/15/2019 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |