|
Device | PARADIGM REAL-TIME REVEL SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S024 |
Date Received | 11/09/2016 |
Decision Date | 01/25/2017 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding the requirement for a chemical exposure durability test to the pump product specifications and for a manufacturing process change of adding an annealing process during the assembly of the pump cases. |