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 PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMPS |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S170 |
Date Received | 11/03/2014 |
Decision Date | 12/03/2014 |
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 TO A REJECTION CRITERION IN THE HARVEST OF USED MOTORS DURING THEMANUFACTURING OF REFURBISHED PUMPS. THE MOTOR IS A PART OF THE INSULIN PUMP IN THE PARADIGMREAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), THE PARADIGM REALTIMEREVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), AND THE MINIMED 530G SYSTEM (MMT-551, MMT-751). |
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