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 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S147 |
Date Received | 11/08/2013 |
Decision Date | 08/21/2014 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF A PNEUMATIC PRESS TOOL IN PLACEOF A MANUAL PRESS TOOL IN THE MANUFACTURING PROCESS OF THE PARADIGM REAL-TIME INSULIN PUMP(MODELS:MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVELINSULIN-PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), GUARDIAN REALTIMEMONITOR (MODELS: CSS7100 AND CSS17100K) AND THE MINIMED 530G INSULIN PUMP(MODELS: MMT-551 AND MMT-751). THESE PARTS ARE COMPONENTS OF THE PARADIGM REAL-TIMESYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CONTINUOUS GLUCOSEMONITORING SYSTEMS AND THE MINIMED 530G SYSTEM RESPECTIVELY. |
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