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 | S097 |
Date Received | 11/02/2016 |
Decision Date | 12/02/2016 |
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 Move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System. |
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