Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | Paradigm REAL-Time Revel System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S201 |
Date Received | 12/20/2017 |
Decision Date | 02/14/2018 |
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 design changes to the battery component of the GST1 transmitter. The GST1 transmitter is a component of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. |
|
|