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 | S108 |
Date Received | 01/24/2012 |
Decision Date | 03/30/2012 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATIVE SUPER CAPACITOR USED ON THE INTERFACEBOARD OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, -522K, -722, -722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, -523K, -723, -723K) WHICH ARE COMPONENTS OF THE CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM. |
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