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 INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K) |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S106 |
Date Received | 12/12/2011 |
Decision Date | 12/28/2011 |
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 CHANGE IN MANUFACTURING LOCATION FROM THAILAND TO MOORPARK, CA FOR CTS ELECTRONICS MANUFACTURING SOLUTIONS, INC. (CTS), THE SUPPLIER OF THE PRINTED CIRCUIT BOARD ASSEMBLIES (PCBA), FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K), WHICH ARE COMPONENTS OF THE DEVICE. |
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