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 PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S129 |
Date Received | 11/15/2012 |
Decision Date | 02/11/2013 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SUBSTITUTING THE CURRENT PVC INSULATION MATERIAL OF THE VIBRATOR MOTOR WIRING OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS: MMT-522, MMT-522K, MMT-523, MMT-523K, MMT-722, MMT-722K, MMT-723, AND MMT-723K) WITH HALOGEN-FREE MATERIAL. |
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