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 | MINIMED 530G INSULIN PUMP |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S052 |
Date Received | 02/17/2015 |
Decision Date | 08/25/2015 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE DSCAP AND CASE BOTTOM TO INCLUDE A METRIC THREAD INTERFACE FOR THE PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS MMT-522, 522K, 523, 523K, 722, 722K, 723, 723K), AND MINIMED 530G INSULIN PUMPS (MODEL NUMBERS MMT-551, 751), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THEMINIMED 530G SYSTEM. |
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