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 | S126 |
Date Received | 11/07/2018 |
Decision Date | 12/07/2018 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Introduce an alternative probe module and manufacturing process for Enlite sensor encapsulation. The Enlite sensor is a component of the MiniMed 530G System, the MiniMed 630G System with SmartGuard, the MiniMed Paradigm Real-Time Revel System, and the MiniMed iPro2 CGM System with Enlite Sensor. |
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