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 | S086 |
Date Received | 03/25/2016 |
Decision Date | 04/21/2016 |
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 Transfer of equipment used for environmental conditioning for printed circuit board assemblies from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Co. (MPROC), Juncos, PR. The circuit board assemblies are used in the Paradigm family of insulin pumps which are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Paradigm REAL-Time Revel System with Enlite Sensor, and the MiniMed 530G System. |
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