|
Device | 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 | S089 |
Date Received | 10/04/2010 |
Decision Date | 10/13/2010 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TRADE NAME CHANGE FOR PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K). THE NEW TRADE NAME FOR THESE INSULIN PUMPS IS PARADIGM REAL-TIME REVEL INSULIN PUMP. |