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 SYSTEM |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S056 |
Date Received | 01/06/2015 |
Decision Date | 03/20/2015 |
Product Code |
OZO |
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 ADDITIONAL MANUFACTURING TESTING TO BE PERFORMED ON A DIFFERENT VERSION OF A COMPONENT USED IN THE MANUFACTURE OF THE MINIMED 530G INSULIN PUMP MMT-551, MMT-751 THAT IS PART OF THE MINIMED 530G SYSTEM. |
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