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 INSULIN PUMP. PARADIGM REAL-TIME REVEL INSULIN PUMP. |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S181 |
Date Received | 11/02/2015 |
Decision Date | 02/01/2016 |
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 to implement a change in the material composition of the loaner pump interior paper foam tray used for packaging the pump, which is a component of the paradigm eal-time, paradigm real-time revel and MiniMed 530G Systems. |
|
|