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. |
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Device | PARADIGM REAL-TIME INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S068 |
Date Received | 02/11/2010 |
Decision Date | 04/05/2010 |
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 MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP TO ADD AN INSULATION PAD TO THE PUMP MOTOR FLEX CABLE AND IS INDICATED FOR CONTINUOUS DELIVERY OF INSULIN AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. IN ADDITION TO DELIVERY OF INSULIN, THE PARADIGM INSULIN PUMP IS DESIGNED TO RECEIVE AND DISPLAY REAL-TIME GLUCOSE VALUES RECEIVED VIA A COMPATIBLE TRANSMITTING DEVICE. |
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