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 | S061 |
Date Received | 02/06/2015 |
Decision Date | 02/22/2016 |
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 a change to the shelf height specification for the Enlite Sensor base (part number 6015277-001). The Enlite Sensor base is a subcomponent of Enlite Sensor model MMT-7008, which is a component of the MiniMed 530G System. |
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