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 | PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S148 |
Date Received | 11/08/2013 |
Decision Date | 12/05/2013 |
Product Codes |
MDS OYC |
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 PC-BASED MANUFACTURING SOFTWARE UPDATE FROM VERSION 2.2A TO VERSION 2.3A AT THE MEDTRONIC MINIMED, NORTHRIDGE FACILITY, AND UPDATE FROM VERSION 2.0D TO VERSION 2.3A AT THE MPROC, JUNCOS FACILITY FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, AND MMT-722K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K), THE GUARDIAN REAL-TIME MONITOR (MODEL: CSS7100) AND THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751). |
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