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 UNSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S125 |
Date Received | 10/31/2012 |
Decision Date | 01/29/2013 |
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 DESIGN CHANGES TO THE DRIVE SUPPORT CAP, CASE BOTTOM BORE AND ADDITIONAL GLUE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-723, MMT-723K), AS COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEM. |
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