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 | S077 |
Date Received | 11/09/2015 |
Decision Date | 12/09/2015 |
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 TO MAKE CHANGES IN THE INCOMING INSPECTION CRITERIA FOR THE BLUE TEST PLUG TO REMOVE THE INSPECTION OF 5 NON-CRITICAL DIMENSIONS. THE BLUE TEST PLUG IS INTENDED FOR USE WITH THE MINILINK TRANSMITTER (MMT-7703) AND IT IS AN ACCESSORY OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G SYSTEMS. |
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