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 PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR. |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S155 |
Date Received | 04/14/2014 |
Decision Date | 05/14/2014 |
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 NEW TOOL TO BE USED IN THE PROCESS OF CURING THE VIBRATOR MOTOR TO THE VIBRATOR MOTOR HOUSING IN THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K), A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), A COMPONENT OF THE PARADIGM REAL-TIME REVELCONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM. |
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